{"paper_id":"45903d97-5603-4288-9fe0-e0951ddc6437","body_text":"Effect of Early Integration of Supportive Care in Addition to Standard Care in Patients with Breast Cancer: A Randomised Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effect of Early Integration of Supportive Care in Addition to Standard Care in Patients with Breast Cancer: A Randomised Controlled Trial Himanshu Varshney, Prateek Maurya, Nishkarsh Gupta, Atul Batra, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7195177/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 02 Feb, 2026 Read the published version in Supportive Care in Cancer → Version 1 posted 9 You are reading this latest preprint version Abstract Purpose Breast cancer is the most common malignancy among women in India, with a significant proportion diagnosed at advanced stages. These patients often endure a high symptom burden and compromised quality of life (QoL). Early integration of supportive care may improve outcomes, yet remains underutilised in resource-limited settings. This study evaluated the effect of early integration of supportive care alongside standard oncology treatment on QoL and symptom burden in breast cancer patients. Methods In this single-centre, randomised controlled trial, 110 newly diagnosed adult female breast cancer patients were randomised (1:1) into an intervention group (early supportive care and standard care) or control group (standard care only). Supportive care included symptom management, psychosocial counselling, and educational support. Outcomes were assessed at baseline and 3 months using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Edmonton Symptom Assessment Scale (ESAS). Statistical analyses included t-tests, multivariate regression, and mediation modelling. Results Both groups showed significant improvement in QoL, but greater symptom reduction was observed in the intervention group (mean ± SD ESAS reduction: 30.69 ± 15.51 vs. 22.9 ± 15.99; p = 0.014). Fatigue and pain were significantly lower in the supportive care group (Cohen's d = 0.55 and 0.38, respectively). The financial burden was also significantly reduced (p = 0.001), accompanied by higher patient and caregiver satisfaction scores (p = 0.032). Mediation analysis confirmed pain reduction as a key predictor of QoL improvement (p < 0.001). Conclusions Early integration of supportive care significantly reduces symptom burden, enhances psychological well-being, and lowers financial stress in breast cancer patients, supporting its inclusion as a standard adjunct to cancer care in developing countries. Trial Registration CTRI/2021/06/034136, Date 10/06/2021 Breast Cancer Supportive Care Quality of Life Symptom Burden Palliative Oncology EORTC QLQ-C30 ESAS India Pain Management Figures Figure 1 Figure 2 Figure 3 Introduction Breast cancer remains a significant global public health challenge, with an estimated 2.3 million new cases diagnosed annually, as reported by GLOBOCAN [ 1 ]. In India, the age-adjusted incidence rate of breast cancer is 25.8 per 100,000 females, contributing significantly to the country's cancer burden [ 2 ]. Alarmingly, over half of Indian breast cancer patients are diagnosed at advanced stages (stage III or IV), where treatment outcomes are less favourable and quality of life is often severely compromised [ 3 ]. The advanced stages of breast cancer are associated with multiple concurrent symptoms, including pain, fatigue, nausea, and significant psychosocial distress, which result in a considerable decline in functional status and overall quality of life (QoL) [ 4 , 5 ]. While curative treatments focus primarily on disease eradication, they often fail to address the physical and emotional dimensions of cancer care comprehensively, frequently undermining patients' well-being [ 6 , 7 ]. Supportive care, particularly when introduced early, aims to alleviate this symptom burden and enhance QoL. Research indicates that early interventions improve quality of life and often result in less aggressive end-of-life care [ 8 ]. Consequently, both the World Health Organisation (WHO) and the American Society of Clinical Oncology (ASCO) emphasise integrating supportive care from the time of diagnosis [ 9 ]. However, the absence of robust early implementation frameworks limits its utilisation, especially in developing nations [ 10 ]. This gap in care highlights the need to formally assess structured interventions. Therefore, the primary objective of this study was to assess the effect of early best supportive care on symptom burden and Quality of Life (QoL) at 3 months in patients with breast cancer. The study hypothesized that the early integration of best supportive care alongside standard oncological treatment would lead to a significant improvement in QoL and a reduction in symptom burden for breast cancer patients when compared to those who receive supportive care only on an on-demand basis. Methods Study Design This single-centre, randomised controlled trial was conducted from January 2022 to June 2023 in adult female patients with histopathologically confirmed breast cancer who had not received any systemic oncology treatment at the time of recruitment (Fig. 1 ). Ethical clearance was obtained from the Institutional Ethics Committee before initiating the study. The trial was registered in the Clinical Trials Registry of India (CTRI/2021/06/034136) before patient enrollment. All recruited patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0–3, could understand Hindi or English, and provided informed consent. Participants were randomly allocated in a 1:1 ratio to one of two groups. The intervention group received early integration of supportive care alongside standard oncology treatment, while the control group received standard care with supportive interventions provided only upon referral by the treating team. Participants Adult female patients who had been recently diagnosed with histopathologically confirmed breast cancer were eligible for inclusion if they had not yet received any systemic oncology treatment, including chemotherapy, radiotherapy, or hormonal therapy, at the time of recruitment. Patients who had undergone diagnostic or therapeutic surgery were eligible, provided no adjuvant systemic treatment had been initiated. All participants were required to have an ECOG performance status of 0–3, indicating ambulatory status, and be able to communicate in either Hindi or English. Written informed consent was obtained from all participants before enrollment. Patients were excluded if they had an ECOG score greater than 3, terminal illness, dementia, severe cognitive impairments, previous cancer-directed systemic treatments, or severe agitation or psychiatric disorders that would compromise study participation or assessment validity. Randomisation and Blinding Block randomisation was employed to ensure group balance, with sequences generated by a computer algorithm and concealed in sequentially numbered, sealed opaque envelopes. Blinding was not implemented due to the nature of the supportive care interventions, which required active participation by both patients and care providers. To minimise bias, outcome assessors were independent researchers not involved in delivering the interventions. Interventions The intervention group received comprehensive early supportive care from the time of cancer diagnosis in addition to standard oncology care. This supportive care program included weekly structured symptom assessments using standardised protocols during the first month, followed by biweekly assessments thereafter. Individual counselling sessions lasting 30–45 minutes were conducted to address pain management, fatigue, anxiety, depression, and stress management techniques. Patients received educational materials and counselling about disease management, treatment side effects, and self-care strategies. The intervention also encompassed nutritional counselling and dietary guidance, psychosocial support with coping strategies training, and financial counselling with coordination to social services when needed. Resource planning assistance was provided for treatment logistics and family support systems, and patients had access to a 24-hour telephone helpline for urgent symptom management queries. The control group received standard oncology care according to institutional protocols, which included treatment modalities such as surgery, chemotherapy, and radiotherapy, as deemed appropriate by the treating oncologist. Supportive care interventions were provided only upon specific referral by the treating oncology team or upon patient request. Outcome Measures The primary outcome was the change in quality of life from baseline to three months, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Secondary outcomes included changes in symptom burden evaluated using the Edmonton Symptom Assessment Scale (ESAS) over the same time period. Permission for use of the EORTC QLQ-C30 was obtained from the EORTC Quality of Life Group. Both validated questionnaires were administered in either Hindi or English, based on the patient's language preference, at baseline and the three-month follow-up by trained research personnel. Sample Size Calculation Sample size calculations were based on detecting a 5-unit difference in quality of life scores between groups. This effect size was consistent with the mean change of 6.8 units observed in a previous trial [ 11 ]. The calculation was performed with 80% statistical power and a 5% significance level. Based on these parameters, a target sample size of 270 patients was initially determined. However, recruitment was limited to 110 patients due to COVID-19 pandemic restrictions and institutional safety protocols that reduced patient flow and limited research activities. Statistical Analysis Continuous variables were analysed using independent t-tests for normally distributed data or Wilcoxon rank-sum tests for non-parametric data. Categorical variables were compared using the chi-square test or Fisher's exact test, as appropriate. Changes from baseline to follow-up within groups were assessed using paired t-tests or Wilcoxon signed-rank tests. Multivariate regression models were constructed to adjust for potential confounders and baseline differences. Mediation analysis was performed to explore pathways through which the intervention affected quality of life outcomes. All statistical analyses were performed using SPSS software version 28.0, with a two-sided significance level of p < 0.05 considered statistically significant. Results The study included 110 participants, with 54 patients in the control group and 56 in the intervention group, ensuring a balanced comparison (Table 1 ). The mean age was 48.8 ± 12.0 years in the intervention group and 48.2 ± 11.0 years in the control group (p = 0.78). Most patients had an ECOG performance status of 1, with 75.0% in the intervention group and 66.7% in the control group (p = 0.35). The demographic and clinical variables were comparable between the two groups, indicating successful randomisation. Table 1 Baseline Characteristics of Participants Demographic Variables Intervention Group (n = 56) Control Group (n = 54) Age Mean ± SD (years) 48.8 ± 12.0 48.2 ± 11.0 21–50 years 31 (55.4%) 30 (55.6%) 51–70 years 23 (41.1%) 23 (42.6%) > 70 years 2 (3.6%) 1 (1.9%) Menopausal Status Pre-menopausal 26 (46.4%) 24 (44.4%) Post-menopausal 30 (53.6%) 30 (55.6%) Treatment Status Post-surgical intervention 12 (21.4%) 9 (16.7%) No prior intervention 44 (78.6%) 45 (83.3%) Time since diagnosis 0–2 months 30 (53.6%) 37 (68.5%) 2–6 months 25 (44.6%) 14 (25.9%) > 6 months 1 (1.8%) 3 (5.6%) ECOG Performance Status 1 42 (75.0%) 36 (66.7%) 2 14 (25.0%) 18 (33.3%) Education Level No formal education 22 (39.3%) 22 (40.7%) Primary education 10 (17.9%) 12 (22.2%) Secondary education 11 (19.6%) 9 (16.7%) Higher education 13 (23.2%) 11 (20.4%) Employment Status Unemployed 46 (82.1%) 39 (72.2%) Employed (full/part-time) 8 (14.3%) 13 (24.1%) Student 2 (3.6%) 2 (3.7%) Family Structure Joint family 29 (51.8%) 32 (59.3%) Nuclear family 26 (46.4%) 20 (37.0%) Living alone 1 (1.8%) 2 (3.7%) Earning Members No earning member 1 (1.8%) 3 (5.6%) One or more earning members 55 (98.2%) 51 (94.4%) Marital Status Married 47 (83.9%) 45 (83.3%) Widowed 6 (10.7%) 7 (13.0%) Separated/Never married 3 (5.4%) 2 (3.7%) Residence Rural 25 (44.6%) 36 (66.7%) Urban 31 (55.4%) 18 (33.3%) Insurance Coverage None 48 (85.7%) 46 (85.2%) Government/Private insurance 8 (14.3%) 8 (14.8%) Primary Tumour Side Left 24 (42.9%) 36 (66.7%) Right 32 (57.1%) 18 (33.3%) Baseline Symptom Burden At baseline, symptom burden was comparable between the groups as measured by the Edmonton Symptom Assessment Scale (ESAS). The median total ESAS score was 35.0 (IQR: 25.8–50.0) in the intervention group compared to 32.0 (IQR: 22.2–47.0) in the control group (p = 0.42). At baseline, symptom burden was largely comparable between groups as measured by ESAS, although dyspnea was significantly higher in the intervention group (p = 0.006; Table 2 ). Table 2 Comparison of ESAS Component Scores Between Groups Component Time Control Group Median (IQR) Intervention Group Median (IQR) p-value Pain Baseline 6.0 (2.0–8.0) 7.0 (4.0–8.0) 0.211 At 3 months 2.0 (1.0–3.0) 1.5 (1.0-1.8) 0.002 Tiredness Baseline 6.0 (4.0–7.0) 5.0 (4.0–7.0) 0.962 At 3 months 2.0 (1.5-3.0) 1.0 (0.5–1.5) < 0.001 Sleep Baseline 3.0 (1.0–6.0) 4.0 (1.0–7.0) 0.757 At 3 months 1.0 (0.0–1.0) 0.0 (0.0-0.5) < 0.001 Nausea Baseline 1.0 (0.0–2.0) 0.0 (0.0-2.2) 0.722 At 3 months 0.0 (0.0–1.0) 0.0 (0.0–0.0) 0.012 Loss of Appetite Baseline 1.0 (0.0–5.0) 1.0 (0.0–5.0) 0.456 At 3 months 2.0 (1.0–2.0) 0.0 (0.0-0.5) < 0.001 Dyspnoea Baseline 0.0 (0.0-0.8) 1.0 (0.0-4.2) 0.006 At 3 months 0.0 (0.0–0.0) 0.0 (0.0–0.0) 0.619 Depression Baseline 6.0 (4.0–6.0) 5.0 (2.8–6.2) 0.734 At 3 months 3.0 (2.0–3.0) 1.0 (0.5–1.5) < 0.001 Stress Baseline 6.0 (6.0-7.8) 6.0 (4.8-7.0) 0.621 At 3 months 3.0 (2.0–3.0) 1.0 (0.5–1.5) < 0.001 Best Health Baseline 5.0 (3.0–7.0) 6.0 (4.0–7.0) 0.415 At 3 months 3.0 (2.0–3.0) 1.0 (0.5–1.5) < 0.001 ESAS Total Baseline 32.0 (22.2–47.0) 35.0 (25.8–50.0) 0.423 At 3 months 14.5 (10.2–17.0) 5.5 (4.0–8.0) < 0.001 Quality of Life Outcomes Both groups demonstrated significant within-group improvements in quality of life from baseline to three months (both p < 0.001). The control group's mean global health status score increased from 53.29 to 68.02, representing a mean change of 14.73 ± 15.63. In the intervention group, the score increased from 49.67 to 72.88, representing a greater mean change of 23.20 ± 22.00. The between-group difference in change scores was statistically significant (p = 0.032), favouring the intervention group (Table 3 ). Table 3 Quality of Life and Symptom Scores by Group Domain Category Intervention Group Control Group Baseline At 3 Months p-value Baseline At 3 Months p-value Global Health Status Global Health Status 50.0 (33.3–66.6) 83.3 (66.6–83.3) < 0.001 50.0 (50.0-66.6) 66.6 (58.3–75.0) < 0.001 Functional Scales Physical Functioning 66.6 (53.3–80.0) 91.6 (80.0-93.3) < 0.001 80.0 (60.0-93.3) 80.0 (80.0-86.6) 0.036 Role Functioning 66.6 (33.3–83.3) 66.6 (66.6–100) < 0.001 66.6 (50.0-83.3) 66.6 (66.6–83.3) 0.043 Emotional Functioning 50.0 (50.0–75.0) 83.3 (83.3–100) < 0.001 58.3 (50.0–75.0) 83.3 (75.0-83.3) < 0.001 Cognitive Functioning 83.3 (66.6–100) 100 (83.3–100) < 0.001 83.3 (66.6–100) 83.3 (83.3–100) 0.006 Social Functioning 66.6 (33.3–66.6) 83.3 (66.6–100) < 0.001 66.6 (50.0-66.6) 50.0 (50.0-66.6) 0.287 Symptom Scales Fatigue 33.3 (22.2–55.5) 11.1 (0.0-22.2) < 0.001 22.2 (22.2–44.4) 22.2 (22.2–33.3) 0.007 Nausea/Vomiting 0.0 (0.0-16.6) 0.0 (0.0–0.0) 0.015 0.0 (0.0-16.6) 0.0 (0.0-16.6) 0.200 Pain 50.0 (33.3–66.6) 16.6 (0.0-33.3) < 0.001 33.3 (33.3–50.0) 16.6 (16.6–33.3) < 0.001 Dyspnoea 0.0 (0.0-33.3) 0.0 (0.0–0.0) 0.000 0.0 (0.0–0.0) 0.0 (0.0–0.0) 0.004 Insomnia 33.3 (0.0-66.6) 0.0 (0.0–0.0) 0.000 33.3 (0.0-66.6) 0.0 (0.0-33.3) < 0.001 Appetite Loss 33.3 (0.0-66.6) 0.0 (0.0-33.3) 0.000 33.3 (33.3–66.6) 33.3 (33.3–33.3) 0.005 Financial Difficulties 33.3 (33.3–66.6) 0.0 (0.0-33.3) 0.000 33.3 (0.0-66.6) 33.3 (33.3–66.6) 0.999 Data presented as median (interquartile range). P-values from Wilcoxon signed-rank tests for within-group changes. Symptom Burden Reduction Both groups exhibited significant reductions in symptom burden from baseline to three months; however, improvements were substantially more pronounced in the intervention group. The mean reduction in the total ESAS score was 30.69 ± 15.51 in the intervention group compared to 22.9 ± 15.99 in the control group (p = 0.014). Specific symptom improvements favoured the intervention group across multiple domains (Fig. 2 ). The mean reduction in the pain score was 4.48 ± 2.08 in the intervention group versus 3.1 ± 2.31 in the control group (p = 0.0075). Fatigue showed significant improvement in both groups, with a greater reduction in the intervention group (t-statistic = 7.21, p = 2.78 × 10⁻⁹) compared to controls (t-statistic = 2.92, p = 5.55 × 10⁻³). Sleep disturbance, depression, stress, and appetite loss all showed significantly greater improvements in the intervention group compared to the control group (all p < 0.001) (Table 2 ). Functional Status and Psychological Outcomes ECOG performance scores remained comparable between the groups at three months (p = 0.452), indicating that both treatment approaches maintained functional status without significant differences between groups. Insomnia improved significantly in both groups; however, between-group comparisons revealed no statistically significant difference (p = 0.921). Financial Burden and Healthcare Utilisation The intervention group experienced a significant reduction in financial burden with a mean change of -26.80 (SD = 28.30) compared to no significant change in the control group (mean change: 0.00, SD = 41.79, p = 0.001). This represented a large effect size (Cohen's d = 0.75) for reducing financial burden. Patient and Caregiver Satisfaction Patient and caregiver satisfaction levels were significantly higher in the intervention group. The mean improvement in global health satisfaction scores was 23.20 (SD = 22.00) in the intervention group compared to 14.73 (SD = 15.63) in the control group (p = 0.032). Predictive and Mediation Analyses Age and ECOG status did not significantly influence treatment outcomes in subgroup analyses. Pain reduction emerged as a key predictor of quality of life improvements, with a strong positive correlation (r = 0.52, p = 0.002). Regression analysis confirmed that pain reduction accounted for 28.9% of the variance in quality of life improvements (R² = 0.289). Mediation analysis revealed that a one-point decrease in pain resulted in a 0.46-point increase in global health scores, confirmed by the Sobel test (p < 0.001) (Fig. 3 ) Effect Size Analysis Effect size analysis demonstrated varying impacts of the intervention across different domains. Fatigue reduction showed a moderate effect size (Cohen's d = 0.55), while pain reduction demonstrated a small to moderate effect (Cohen's d = 0.38). Financial burden reduction exhibited the largest effect size (Cohen's d = 0.75), indicating substantial clinical significance of the economic benefits associated with early supportive care. Discussion The integration of early supportive care into oncology treatment paradigms has increasingly been recognised as a vital approach for addressing the multifactorial needs of patients with advanced cancer. Our study provides evidence that early supportive care, when initiated alongside standard oncologic treatment, yields substantial benefits across multiple domains, including symptom control, quality of life, psychological well-being, financial burden, and overall patient satisfaction. Symptom Control and Quality of Life A key strength of our study lies in the significant reduction of symptom burden achieved in the intervention group across nearly all domains assessed by the Edmonton Symptom Assessment Scale. Patients receiving early supportive care reported pronounced improvements in pain, fatigue, sleep disturbance, depression, appetite loss, and overall well-being. These findings align with those of Bandieri et al., who demonstrated meaningful symptom relief in patients with advanced cancer following early palliative care. However, between-group differences were sometimes less pronounced than observed in our study [ 10 ]. The landmark trial by Temel et al. found that patients with non-small-cell lung cancer who received early palliative care experienced significantly reduced symptom severity and improved mood compared to those receiving standard care alone [ 8 ]. Our findings echo these results, particularly in the domains of fatigue and psychological stress, reinforcing the notion that early supportive interventions enhance both physical and emotional well-being. Both the intervention and control groups in our study exhibited significant within-group improvements in quality of life; however, the supportive care group demonstrated significantly greater improvement in change scores. This finding aligns with the results of Greer et al., who reported quality of life improvements in patients receiving early palliative care [ 12 ]. The PACO trial by Allende et al. found that early integration of palliative care in NSCLC patients significantly improved both quality of life and survival, with benefits more pronounced in individuals with higher baseline scores, suggesting that earlier initiation may be key to maximising effectiveness [ 13 ]. Economic Impact One of the most novel aspects of our study is the significant reduction in financial burden experienced by patients in the intervention group. While economic outcomes are often underreported in supportive care trials, our findings demonstrate that early supportive care can substantially alleviate the financial toxicity associated with cancer treatment. The intervention group reported a marked decrease in financial distress, whereas the control group showed no change, highlighting the role of comprehensive supportive care in mitigating indirect treatment burdens. This observation is supported by Greer et al., who reported that early palliative care led to lower average healthcare expenditures, particularly through decreased chemotherapy use in the final stages of life [ 12 ]. The American Society of Clinical Oncology has formally recognised the cost-saving potential of early palliative integration, advocating for early combination of palliative and standard oncologic care as a strategy to enhance patient outcomes while reducing resource-intensive interventions [ 14 ]. Psychological and Functional Outcomes Patients in the intervention group exhibited greater reductions in fatigue, depression, and stress compared to those receiving standard care. These results are consistent with findings from Datta et al., who observed improved emotional well-being among lung cancer patients receiving early integrated palliative care in India [ 15 ]. Despite improvements in symptom burden and emotional well-being, our study found no significant differences in ECOG performance status between groups, suggesting that while early supportive care enhances subjective well-being, its impact on objective functional measures may require longer evaluation periods. Mechanistic Insights Through mediation analysis, we demonstrated that pain reduction was a significant predictor of quality of life improvement, explaining nearly 29% of the variance in global health outcomes. This finding enhances our understanding of the pathways through which early supportive care achieves benefits and underscores the importance of proactively addressing specific symptom domains. The strong correlation between pain management and overall quality of life improvements suggests that targeted symptom control may be a key mechanism underlying the broader benefits of comprehensive supportive care. Study Limitations Several limitations warrant consideration. The reduced sample size (110 versus the planned 270 patients) due to COVID-19 pandemic restrictions may have limited statistical power to detect smaller effect sizes, although significant effects were observed across key outcomes. The single-centre design may limit generalizability to other healthcare settings. The inability to blind participants and care providers due to the nature of interventions may have introduced bias, although independent outcome assessors were used to minimise this limitation. Additionally, the three-month follow-up period may not capture long-term benefits or the sustainability of the intervention effects. Clinical Implications Our findings support the integration of early supportive care as a standard component of breast cancer management, particularly in resource-limited settings. The significant improvements in symptom control, quality of life, and financial burden, combined with high patient satisfaction, provide compelling evidence for the routine implementation of this approach. The intervention's effectiveness across multiple domains suggests that early supportive care should not be viewed as an optional addition but rather as an integral component of comprehensive cancer care. Conclusion The findings of this study strongly support the integration of early supportive care in the management of breast cancer. The intervention significantly reduced symptom burden—particularly pain, fatigue, depression, and stress—while also improving quality of life and alleviating financial strain. Additionally, patient and caregiver satisfaction were notably higher in the intervention group, reinforcing the clinical benefits of early supportive care. Early integration of supportive care significantly reduces symptom burden, enhances psychological well-being, and lowers financial stress in breast cancer patients, supporting its inclusion as a standard adjunct to cancer care in developing countries. Declarations Funding The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. Competing Interests: The authors have no relevant financial or non-financial interests to disclose. Ethics Approval : This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Institutional Ethics Committee of the All India Institute of Medical Sciences, New Delhi (No. IECPG-207/24.03.2021, RT -03/28.05.2021).. Consent to Participate: Informed consent was obtained from all individual participants included in the study. Consent to Publish : Not applicable. Data Availability : The datasets generated and analysed during the current study are available as a supplementary material. Author Contributions N.G., A.B., and H.V. conceptualized the study. N.G., A.B., R.K.M., and H.V. developed the methodology. H.V. and P.M. prepared the original draft. N.G., A.B., A.G., B.K.R., V.K., R.K.M., S.J.B. reviewed and edited the manuscript. S.B., S.M., R.G., and S.J.B. supervised the work. All authors read and approved the final manuscript. Acknowledgements The authors would like to acknowledge the following individuals for their support and contributions: Dr. Saurabh Vig, Dr. Anuja Pandit, Dr. Shweta Bhopale, Dr. Balbir Kumar (Associate professor, Onco-Anesthesia & Palliative Medicine, NCI-Jhajjar, AIIMS, New Delhi) Dr. Prashant Sirohiya, Dr. Raghav Gupta, Dr. Bhanu Pratap Maurya, Dr. Puneet Rathore (Assistant professor, Onco-Anesthesia & Palliative Medicine, NCI-Jhajjar, AIIMS, New Delhi) Dr. Vikram Pratap Singh (Assistant professor, Palliative Medicine, Delhi State Cancer Hospital, New Delhi) References Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA A Cancer J Clinicians 2021;71:209–49. Malvia S, Bagadi SA, Dubey US, Saxena S. Epidemiology of breast cancer in Indian women. Asia-Pacific Journal of Clinical Oncology 2017;13. Mathur P, Sathishkumar K, Chaturvedi M, Das P, Sudarshan K, Santhappan S, et al. Cancer Statistics, 2020: Report From National Cancer Registry Programme, India. JCO Global Oncology 2020;6. Medina J de MR, Trugilho I de A, Mendes GNB, Silva JG, Paiva MA da S, Aguiar SS de, et al. Advanced Clinical Stage at Diagnosis of Breast Cancer Is Associated with Poorer Health-Related Quality of Life: A Cross-Sectional Study. European Journal of Breast Health 2019;15:26–31. Lima E, Silva M. Quality of life of women with locally advanced or metastatic breast cancer. Revista Gaucha de Enfermagem 2020;41. Janz NK, Friese CR, Li Y, Graff JJ, Hamilton AS, Hawley ST. Emotional well-being years post-treatment for breast cancer: prospective, multi-ethnic, and population-based analysis. J Cancer Surviv 2014;8:131–42. Ligt KMD, Heins M, Verloop J, Ezendam N, Smorenburg C, Korevaar J, et al. The impact of health symptoms on health-related quality of life in early-stage breast cancer survivors. Breast Cancer Research and Treatment 2019;178:703–11. Temel J, Greer J, Muzikansky A, Gallagher E, Admane S, Jackson V, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. The New England Journal of Medicine 2010;363:733–42. Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, et al. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. The Lancet 2014;383:1721–30. Bandieri E, Banchelli F, Artioli F, Mucciarini C, Razzini G, Cruciani M, et al. Early versus delayed palliative/supportive care in advanced cancer: an observational study. BMJ Supportive & Palliative Care 2019;10:32–32. Vanbutsele G, Van Belle S, Surmont V, De Laat M, Colman R, Eecloo K, et al. The effect of early and systematic integration of palliative care in oncology on quality of life and health care use near the end of life: A randomised controlled trial. European Journal of Cancer 2020;124:186–93. https://doi.org/10.1016/j.ejca.2019.11.009 . Greer JA, Tramontano A, McMahon PM, El-Jawahri A, Parikh RB, Gallagher ER, et al. Cost analysis of a randomized trial of early palliative care (PC) in patients with metastatic non-small cell lung cancer (NSCLC). JCO 2014;32:4–4. Allende S, Turcott JG, Verástegui E, Rodríguez-Mayoral O, Flores-Estrada D, Pérez Camargo DA, et al. Early Incorporation to Palliative Care (EPC) in Patients With Advanced Non-Small Cell Lung Cancer: The PACO Randomized Clinical Trial. The Oncologist 2024;29:e1373–85. Smith TJ, Temin S, Alesi ER, Abernethy AP, Balboni TA, Basch EM, et al. American Society of Clinical Oncology Provisional Clinical Opinion: The Integration of Palliative Care Into Standard Oncology Care. JCO 2012;30:880–7. Datta A, Ostwal S, Das A. Role of Symptomatic Management in Understanding Effects of Early Integration of Palliative Care among Nonmetastatic Lung Cancer Patients on Psychological Well-Being. European Journal of Cancer Care 2024. Additional Declarations No competing interests reported. Supplementary Files THESISMASTERCHARTSUBMISSIONSCC.xlsx Cite Share Download PDF Status: Published Journal Publication published 02 Feb, 2026 Read the published version in Supportive Care in Cancer → Version 1 posted Editorial decision: Revision requested 20 Oct, 2025 Reviews received at journal 20 Oct, 2025 Reviews received at journal 11 Oct, 2025 Reviewers agreed at journal 30 Sep, 2025 Reviewers agreed at journal 19 Sep, 2025 Reviewers invited by journal 26 Aug, 2025 Editor assigned by journal 26 Aug, 2025 Submission checks completed at journal 28 Jul, 2025 First submitted to journal 23 Jul, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {\"props\":{\"pageProps\":{\"initialData\":{\"identity\":\"rs-7195177\",\"acceptedTermsAndConditions\":true,\"allowDirectSubmit\":false,\"archivedVersions\":[],\"articleType\":\"Research Article\",\"associatedPublications\":[],\"authors\":[{\"id\":506007539,\"identity\":\"78bcceef-3931-4c29-a26d-dee59c46bc99\",\"order_by\":0,\"name\":\"Himanshu Varshney\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R. Ambedkar Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Himanshu\",\"middleName\":\"\",\"lastName\":\"Varshney\",\"suffix\":\"\"},{\"id\":506007540,\"identity\":\"96275451-5bad-4f42-971e-f8783d7ed17a\",\"order_by\":1,\"name\":\"Prateek Maurya\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R. Ambedkar Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Prateek\",\"middleName\":\"\",\"lastName\":\"Maurya\",\"suffix\":\"\"},{\"id\":506007541,\"identity\":\"c9f65111-15e4-4acf-961e-b7ae867ab9d8\",\"order_by\":2,\"name\":\"Nishkarsh Gupta\",\"email\":\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABCklEQVRIiWNgGAWjYDCCA0DE2JAAZPEwPmBgYOZhbwYKJRQQp4XZAKSF5xiQk2CAXwsDVAubBFALA1gLAx4tfLfPHjz4c0eavHn/2WPVFRXWMjxs3IkfHhgwyPOLHcCqRfJcXsJh3jM5hnNu5KXdPHMmnYeHjXezBNBhhjNnJ2DVYnCGx+AwY1sF4wwJHrObjW2HeezlezeAtCQY3Mat5eDPtgr7GfxnzAob/x0G2/KDkJYDvG05iTMYcswYGxvAWrbhtUUS5DDetrTkGRI5xpINx8B+2WaRYCCB0y98Z3iMP/5sS7YFOszwY0ONtT3IYTd/VNjI80tj14ITSJCmfBSMglEwCkYBCgAAYsFdtRWaNVUAAAAASUVORK5CYII=\",\"orcid\":\"\",\"institution\":\"Dr. B.R. Ambedkar Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":true,\"prefix\":\"\",\"firstName\":\"Nishkarsh\",\"middleName\":\"\",\"lastName\":\"Gupta\",\"suffix\":\"\"},{\"id\":506007542,\"identity\":\"d401a497-e1de-4170-9d0c-468806b00c13\",\"order_by\":3,\"name\":\"Atul Batra\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R.A. Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Atul\",\"middleName\":\"\",\"lastName\":\"Batra\",\"suffix\":\"\"},{\"id\":506007543,\"identity\":\"5c887a8f-522f-4725-8bb5-ac3d753558da\",\"order_by\":4,\"name\":\"Ajay Gogia\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R.A. Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Ajay\",\"middleName\":\"\",\"lastName\":\"Gogia\",\"suffix\":\"\"},{\"id\":506007544,\"identity\":\"e1b1a17c-d2b6-4e12-8cee-a20565680aad\",\"order_by\":5,\"name\":\"Brajesh Kumar Ratre\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R. Ambedkar Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Brajesh\",\"middleName\":\"Kumar\",\"lastName\":\"Ratre\",\"suffix\":\"\"},{\"id\":506007545,\"identity\":\"ab83128f-2b38-4169-b312-d87052ffb249\",\"order_by\":6,\"name\":\"Sachidanand Jee Bharati\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R. Ambedkar Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Sachidanand\",\"middleName\":\"Jee\",\"lastName\":\"Bharati\",\"suffix\":\"\"},{\"id\":506007546,\"identity\":\"1a3d5970-edbb-408e-97fe-43dc5f92a635\",\"order_by\":7,\"name\":\"Vinod Kumar\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R. Ambedkar Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Vinod\",\"middleName\":\"\",\"lastName\":\"Kumar\",\"suffix\":\"\"},{\"id\":506007547,\"identity\":\"52476641-7a84-4db5-a8ca-fa8429f555ca\",\"order_by\":8,\"name\":\"Rakesh Garg\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R. Ambedkar Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Rakesh\",\"middleName\":\"\",\"lastName\":\"Garg\",\"suffix\":\"\"},{\"id\":506007548,\"identity\":\"f5807bf5-30f8-44f2-b16d-143dec5d687b\",\"order_by\":9,\"name\":\"Rajiv Kumar Malhotra\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R. Ambedkar Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Rajiv\",\"middleName\":\"Kumar\",\"lastName\":\"Malhotra\",\"suffix\":\"\"},{\"id\":506007549,\"identity\":\"ade5c496-d6e5-480a-aacd-253c448c479a\",\"order_by\":10,\"name\":\"Seema Mishra\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Dr. B.R. Ambedkar Institute Rotary Cancer Hospital (DRBRAIRCH), All India Institute of Medical Sciences (AIIMS)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Seema\",\"middleName\":\"\",\"lastName\":\"Mishra\",\"suffix\":\"\"},{\"id\":506007550,\"identity\":\"40c420c3-cb1a-4182-80d6-7156ab46ff2d\",\"order_by\":11,\"name\":\"Sushma Bhatnagar\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Apollo Hospital, Sarita Vihar\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Sushma\",\"middleName\":\"\",\"lastName\":\"Bhatnagar\",\"suffix\":\"\"}],\"badges\":[],\"createdAt\":\"2025-07-23 10:23:14\",\"currentVersionCode\":1,\"declarations\":\"\",\"doi\":\"10.21203/rs.3.rs-7195177/v1\",\"doiUrl\":\"https://doi.org/10.21203/rs.3.rs-7195177/v1\",\"draftVersion\":[],\"editorialEvents\":[{\"content\":\"https://doi.org/10.1007/s00520-026-10401-x\",\"type\":\"published\",\"date\":\"2026-02-02T15:59:16+00:00\"}],\"editorialNote\":\"\",\"failedWorkflow\":false,\"files\":[{\"id\":90542572,\"identity\":\"fa02bf63-3163-4d71-8721-169601b0f396\",\"added_by\":\"auto\",\"created_at\":\"2025-09-04 00:04:58\",\"extension\":\"png\",\"order_by\":1,\"title\":\"Figure 1\",\"display\":\"\",\"copyAsset\":false,\"role\":\"figure\",\"size\":207123,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003e\\u003cstrong\\u003eConsort Flow Diagram of Participant Enrollment and Follow-Up\\u003c/strong\\u003e\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"floatimage1.png\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-7195177/v1/aeed2fc8714905da48b65ad0.png\"},{\"id\":90541506,\"identity\":\"6e66df10-4e6a-450a-bbda-bec5686b19a2\",\"added_by\":\"auto\",\"created_at\":\"2025-09-03 23:56:58\",\"extension\":\"png\",\"order_by\":2,\"title\":\"Figure 2\",\"display\":\"\",\"copyAsset\":false,\"role\":\"figure\",\"size\":54267,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003e\\u003cstrong\\u003eMean ± SD improvement for each ESAS component and the total score\\u003c/strong\\u003e\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"floatimage2.png\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-7195177/v1/58798fe858fab498f3b7edfe.png\"},{\"id\":90541517,\"identity\":\"d5c8fc91-2907-4e34-923a-b99c77ccac26\",\"added_by\":\"auto\",\"created_at\":\"2025-09-03 23:56:59\",\"extension\":\"jpeg\",\"order_by\":3,\"title\":\"Figure 3\",\"display\":\"\",\"copyAsset\":false,\"role\":\"figure\",\"size\":165832,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003e\\u003cstrong\\u003eMediation analysis demonstrating how symptom reduction mediates the effect of early supportive care on quality of life (QoL) improvement. The pathway begins with the early supportive care intervention, which significantly reduces symptom burden, including pain, as indicated by Path a (coefficient = -8.65, p \\u0026lt; 0.001). This reduction in symptoms, in turn, leads to an improvement in QoL, as shown in Path b (coefficient = -0.46, p \\u0026lt; 0.001). The total effect of early supportive care on QoL improvement is quantified as 8.47 (Path c), highlighting the intervention's overall benefit. However, when symptom reduction is accounted for, the direct effect of the intervention on QoL improvement decreases to 4.68 (Path c'), indicating that symptom relief partially mediates the relationship between early supportive care and QoL enhancement.\\u003c/strong\\u003e\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"floatimage3.jpeg\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-7195177/v1/0690290af9851228e1536e7c.jpeg\"},{\"id\":102234184,\"identity\":\"14f350d9-82eb-4385-bf55-e8f7d6f6929b\",\"added_by\":\"auto\",\"created_at\":\"2026-02-09 16:07:20\",\"extension\":\"pdf\",\"order_by\":0,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"manuscript-pdf\",\"size\":1980078,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"manuscript.pdf\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-7195177/v1/94875d4d-7b2a-4b4a-a021-d18f1e6b839d.pdf\"},{\"id\":90541507,\"identity\":\"a8eb51f0-4af0-4484-8bea-b838abf98b99\",\"added_by\":\"auto\",\"created_at\":\"2025-09-03 23:56:58\",\"extension\":\"xlsx\",\"order_by\":0,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"supplement\",\"size\":45730,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"THESISMASTERCHARTSUBMISSIONSCC.xlsx\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-7195177/v1/a35a98f3235630429d65532f.xlsx\"}],\"financialInterests\":\"No competing interests reported.\",\"formattedTitle\":\"Effect of Early Integration of Supportive Care in Addition to Standard Care in Patients with Breast Cancer: A Randomised Controlled Trial\",\"fulltext\":[{\"header\":\"Introduction\",\"content\":\"\\u003cp\\u003eBreast cancer remains a significant global public health challenge, with an estimated 2.3\\u0026nbsp;million new cases diagnosed annually, as reported by GLOBOCAN [\\u003cspan citationid=\\\"CR1\\\" class=\\\"CitationRef\\\"\\u003e1\\u003c/span\\u003e]. In India, the age-adjusted incidence rate of breast cancer is 25.8 per 100,000 females, contributing significantly to the country's cancer burden [\\u003cspan citationid=\\\"CR2\\\" class=\\\"CitationRef\\\"\\u003e2\\u003c/span\\u003e]. Alarmingly, over half of Indian breast cancer patients are diagnosed at advanced stages (stage III or IV), where treatment outcomes are less favourable and quality of life is often severely compromised [\\u003cspan citationid=\\\"CR3\\\" class=\\\"CitationRef\\\"\\u003e3\\u003c/span\\u003e].\\u003c/p\\u003e\\u003cp\\u003eThe advanced stages of breast cancer are associated with multiple concurrent symptoms, including pain, fatigue, nausea, and significant psychosocial distress, which result in a considerable decline in functional status and overall quality of life (QoL) [\\u003cspan citationid=\\\"CR4\\\" class=\\\"CitationRef\\\"\\u003e4\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR5\\\" class=\\\"CitationRef\\\"\\u003e5\\u003c/span\\u003e]. While curative treatments focus primarily on disease eradication, they often fail to address the physical and emotional dimensions of cancer care comprehensively, frequently undermining patients' well-being [\\u003cspan citationid=\\\"CR6\\\" class=\\\"CitationRef\\\"\\u003e6\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR7\\\" class=\\\"CitationRef\\\"\\u003e7\\u003c/span\\u003e]. Supportive care, particularly when introduced early, aims to alleviate this symptom burden and enhance QoL. Research indicates that early interventions improve quality of life and often result in less aggressive end-of-life care [\\u003cspan citationid=\\\"CR8\\\" class=\\\"CitationRef\\\"\\u003e8\\u003c/span\\u003e]. Consequently, both the World Health Organisation (WHO) and the American Society of Clinical Oncology (ASCO) emphasise integrating supportive care from the time of diagnosis [\\u003cspan citationid=\\\"CR9\\\" class=\\\"CitationRef\\\"\\u003e9\\u003c/span\\u003e].\\u003c/p\\u003e\\u003cp\\u003eHowever, the absence of robust early implementation frameworks limits its utilisation, especially in developing nations [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e]. This gap in care highlights the need to formally assess structured interventions.\\u003c/p\\u003e\\u003cp\\u003eTherefore, the primary objective of this study was to assess the effect of early best supportive care on symptom burden and Quality of Life (QoL) at 3 months in patients with breast cancer. The study hypothesized that the early integration of best supportive care alongside standard oncological treatment would lead to a significant improvement in QoL and a reduction in symptom burden for breast cancer patients when compared to those who receive supportive care only on an on-demand basis.\\u003c/p\\u003e\"},{\"header\":\"Methods\",\"content\":\"\\u003cp\\u003e\\u003cb\\u003eStudy Design\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eThis single-centre, randomised controlled trial was conducted from January 2022 to June 2023 in adult female patients with histopathologically confirmed breast cancer who had not received any systemic oncology treatment at the time of recruitment (Fig.\\u0026nbsp;\\u003cspan refid=\\\"Fig1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e). Ethical clearance was obtained from the Institutional Ethics Committee before initiating the study. The trial was registered in the Clinical Trials Registry of India (CTRI/2021/06/034136) before patient enrollment. All recruited patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0\\u0026ndash;3, could understand Hindi or English, and provided informed consent.\\u003c/p\\u003e\\u003cp\\u003e\\u003c/p\\u003e\\u003cp\\u003eParticipants were randomly allocated in a 1:1 ratio to one of two groups. The intervention group received early integration of supportive care alongside standard oncology treatment, while the control group received standard care with supportive interventions provided only upon referral by the treating team.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eParticipants\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eAdult female patients who had been recently diagnosed with histopathologically confirmed breast cancer were eligible for inclusion if they had not yet received any systemic oncology treatment, including chemotherapy, radiotherapy, or hormonal therapy, at the time of recruitment. Patients who had undergone diagnostic or therapeutic surgery were eligible, provided no adjuvant systemic treatment had been initiated. All participants were required to have an ECOG performance status of 0\\u0026ndash;3, indicating ambulatory status, and be able to communicate in either Hindi or English. Written informed consent was obtained from all participants before enrollment.\\u003c/p\\u003e\\u003cp\\u003ePatients were excluded if they had an ECOG score greater than 3, terminal illness, dementia, severe cognitive impairments, previous cancer-directed systemic treatments, or severe agitation or psychiatric disorders that would compromise study participation or assessment validity.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eRandomisation and Blinding\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eBlock randomisation was employed to ensure group balance, with sequences generated by a computer algorithm and concealed in sequentially numbered, sealed opaque envelopes. Blinding was not implemented due to the nature of the supportive care interventions, which required active participation by both patients and care providers. To minimise bias, outcome assessors were independent researchers not involved in delivering the interventions.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eInterventions\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eThe intervention group received comprehensive early supportive care from the time of cancer diagnosis in addition to standard oncology care. This supportive care program included weekly structured symptom assessments using standardised protocols during the first month, followed by biweekly assessments thereafter. Individual counselling sessions lasting 30\\u0026ndash;45 minutes were conducted to address pain management, fatigue, anxiety, depression, and stress management techniques. Patients received educational materials and counselling about disease management, treatment side effects, and self-care strategies. The intervention also encompassed nutritional counselling and dietary guidance, psychosocial support with coping strategies training, and financial counselling with coordination to social services when needed. Resource planning assistance was provided for treatment logistics and family support systems, and patients had access to a 24-hour telephone helpline for urgent symptom management queries.\\u003c/p\\u003e\\u003cp\\u003eThe control group received standard oncology care according to institutional protocols, which included treatment modalities such as surgery, chemotherapy, and radiotherapy, as deemed appropriate by the treating oncologist. Supportive care interventions were provided only upon specific referral by the treating oncology team or upon patient request.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eOutcome Measures\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eThe primary outcome was the change in quality of life from baseline to three months, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Secondary outcomes included changes in symptom burden evaluated using the Edmonton Symptom Assessment Scale (ESAS) over the same time period. Permission for use of the EORTC QLQ-C30 was obtained from the EORTC Quality of Life Group. Both validated questionnaires were administered in either Hindi or English, based on the patient's language preference, at baseline and the three-month follow-up by trained research personnel.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eSample Size Calculation\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eSample size calculations were based on detecting a 5-unit difference in quality of life scores between groups. This effect size was consistent with the mean change of 6.8 units observed in a previous trial [\\u003cspan citationid=\\\"CR11\\\" class=\\\"CitationRef\\\"\\u003e11\\u003c/span\\u003e]. The calculation was performed with 80% statistical power and a 5% significance level. Based on these parameters, a target sample size of 270 patients was initially determined. However, recruitment was limited to 110 patients due to COVID-19 pandemic restrictions and institutional safety protocols that reduced patient flow and limited research activities.\\u003c/p\\u003e\\u003cdiv id=\\\"Sec2\\\" class=\\\"Section2\\\"\\u003e\\u003ch2\\u003eStatistical Analysis\\u003c/h2\\u003e\\u003cp\\u003eContinuous variables were analysed using independent t-tests for normally distributed data or Wilcoxon rank-sum tests for non-parametric data. Categorical variables were compared using the chi-square test or Fisher's exact test, as appropriate. Changes from baseline to follow-up within groups were assessed using paired t-tests or Wilcoxon signed-rank tests. Multivariate regression models were constructed to adjust for potential confounders and baseline differences. Mediation analysis was performed to explore pathways through which the intervention affected quality of life outcomes. All statistical analyses were performed using SPSS software version 28.0, with a two-sided significance level of p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.05 considered statistically significant.\\u003c/p\\u003e\\u003c/div\\u003e\"},{\"header\":\"Results\",\"content\":\"\\u003cp\\u003eThe study included 110 participants, with 54 patients in the control group and 56 in the intervention group, ensuring a balanced comparison (Table\\u0026nbsp;\\u003cspan refid=\\\"Tab1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e). The mean age was 48.8\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;12.0 years in the intervention group and 48.2\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;11.0 years in the control group (p\\u0026thinsp;=\\u0026thinsp;0.78). Most patients had an ECOG performance status of 1, with 75.0% in the intervention group and 66.7% in the control group (p\\u0026thinsp;=\\u0026thinsp;0.35). The demographic and clinical variables were comparable between the two groups, indicating successful randomisation.\\u003c/p\\u003e\\u003cp\\u003e\\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab1\\\" border=\\\"1\\\"\\u003e\\u003ccaption language=\\\"En\\\"\\u003e\\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 1\\u003c/div\\u003e\\u003cdiv class=\\\"CaptionContent\\\"\\u003e\\u003cp\\u003eBaseline Characteristics of Participants\\u003c/p\\u003e\\u003c/div\\u003e\\u003c/caption\\u003e\\u003ccolgroup cols=\\\"3\\\"\\u003e\\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e\\u003cthead\\u003e\\u003ctr\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eDemographic Variables\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eIntervention Group (n\\u0026thinsp;=\\u0026thinsp;56)\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003eControl Group (n\\u0026thinsp;=\\u0026thinsp;54)\\u003c/p\\u003e\\u003c/th\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eAge\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e\\u003c/tr\\u003e\\u003c/thead\\u003e\\u003ctbody\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eMean\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;SD (years)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e48.8\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;12.0\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e48.2\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;11.0\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e21\\u0026ndash;50 years\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e31 (55.4%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e30 (55.6%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e51\\u0026ndash;70 years\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e23 (41.1%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e23 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(46.4%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e24 (44.4%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003ePost-menopausal\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e30 (53.6%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e30 (55.6%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eTreatment Status\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003ePost-surgical 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colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e0\\u0026ndash;2 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e30 (53.6%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e37 (68.5%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e2\\u0026ndash;6 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e25 (44.6%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e14 (25.9%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u0026gt;\\u0026thinsp;6 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e1 (1.8%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e3 (5.6%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eECOG Performance Status\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e1\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e42 (75.0%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e36 (66.7%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e2\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e14 (25.0%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e18 (33.3%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eEducation Level\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eNo formal education\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e22 (39.3%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e22 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colname=\\\"c2\\\"\\u003e\\u003cp\\u003e13 (23.2%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e11 (20.4%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eEmployment Status\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eUnemployed\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e46 (82.1%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e39 (72.2%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" 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colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eJoint family\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e29 (51.8%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e32 (59.3%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eNuclear family\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e26 (46.4%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e20 (37.0%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eLiving alone\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e1 (1.8%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e2 (3.7%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eEarning Members\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eNo earning member\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e1 (1.8%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e3 (5.6%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eOne or more earning members\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e55 (98.2%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e51 (94.4%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eMarital Status\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eMarried\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e47 (83.9%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e45 (83.3%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eWidowed\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e6 (10.7%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e7 (13.0%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eSeparated/Never married\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e3 (5.4%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e2 (3.7%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eResidence\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eRural\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e25 (44.6%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e36 (66.7%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eUrban\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e31 (55.4%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e18 (33.3%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eInsurance Coverage\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eNone\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e48 (85.7%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e46 (85.2%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eGovernment/Private insurance\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e8 (14.3%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e8 (14.8%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003ePrimary Tumour Side\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eLeft\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e24 (42.9%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e36 (66.7%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eRight\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003e32 (57.1%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e18 (33.3%)\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003c/tbody\\u003e\\u003c/colgroup\\u003e\\u003c/table\\u003e\\u003c/div\\u003e\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eBaseline Symptom Burden\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eAt baseline, symptom burden was comparable between the groups as measured by the Edmonton Symptom Assessment Scale (ESAS). The median total ESAS score was 35.0 (IQR: 25.8\\u0026ndash;50.0) in the intervention group compared to 32.0 (IQR: 22.2\\u0026ndash;47.0) in the control group (p\\u0026thinsp;=\\u0026thinsp;0.42). At baseline, symptom burden was largely comparable between groups as measured by ESAS, although dyspnea was significantly higher in the intervention group (p\\u0026thinsp;=\\u0026thinsp;0.006; Table\\u0026nbsp;\\u003cspan refid=\\\"Tab2\\\" class=\\\"InternalRef\\\"\\u003e2\\u003c/span\\u003e).\\u003c/p\\u003e\\u003cp\\u003e\\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab2\\\" border=\\\"1\\\"\\u003e\\u003ccaption language=\\\"En\\\"\\u003e\\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 2\\u003c/div\\u003e\\u003cdiv class=\\\"CaptionContent\\\"\\u003e\\u003cp\\u003eComparison of ESAS Component Scores Between Groups\\u003c/p\\u003e\\u003c/div\\u003e\\u003c/caption\\u003e\\u003ccolgroup cols=\\\"5\\\"\\u003e\\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c4\\\" colnum=\\\"4\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c5\\\" colnum=\\\"5\\\"\\u003e\\u003c/div\\u003e\\u003cthead\\u003e\\u003ctr\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eComponent\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eTime\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003eControl Group Median (IQR)\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003eIntervention Group Median (IQR)\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003ep-value\\u003c/p\\u003e\\u003c/th\\u003e\\u003c/tr\\u003e\\u003c/thead\\u003e\\u003ctbody\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003ePain\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e6.0 (2.0\\u0026ndash;8.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e7.0 (4.0\\u0026ndash;8.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.211\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e2.0 (1.0\\u0026ndash;3.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e1.5 (1.0-1.8)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.002\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eTiredness\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e6.0 (4.0\\u0026ndash;7.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e5.0 (4.0\\u0026ndash;7.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.962\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e2.0 (1.5-3.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e1.0 (0.5\\u0026ndash;1.5)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eSleep\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e3.0 (1.0\\u0026ndash;6.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e4.0 (1.0\\u0026ndash;7.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.757\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e1.0 (0.0\\u0026ndash;1.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0-0.5)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eNausea\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e1.0 (0.0\\u0026ndash;2.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0-2.2)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.722\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e0.0 (0.0\\u0026ndash;1.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0\\u0026ndash;0.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.012\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eLoss of Appetite\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e1.0 (0.0\\u0026ndash;5.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e1.0 (0.0\\u0026ndash;5.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.456\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e2.0 (1.0\\u0026ndash;2.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0-0.5)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eDyspnoea\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e0.0 (0.0-0.8)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e1.0 (0.0-4.2)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.006\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e0.0 (0.0\\u0026ndash;0.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0\\u0026ndash;0.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.619\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eDepression\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e6.0 (4.0\\u0026ndash;6.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e5.0 (2.8\\u0026ndash;6.2)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.734\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e3.0 (2.0\\u0026ndash;3.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e1.0 (0.5\\u0026ndash;1.5)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eStress\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e6.0 (6.0-7.8)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e6.0 (4.8-7.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.621\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e3.0 (2.0\\u0026ndash;3.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e1.0 (0.5\\u0026ndash;1.5)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eBest Health\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e5.0 (3.0\\u0026ndash;7.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e6.0 (4.0\\u0026ndash;7.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.415\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e3.0 (2.0\\u0026ndash;3.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e1.0 (0.5\\u0026ndash;1.5)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eESAS Total\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e32.0 (22.2\\u0026ndash;47.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e35.0 (25.8\\u0026ndash;50.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.423\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAt 3 months\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e14.5 (10.2\\u0026ndash;17.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e5.5 (4.0\\u0026ndash;8.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003c/tbody\\u003e\\u003c/colgroup\\u003e\\u003c/table\\u003e\\u003c/div\\u003e\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eQuality of Life Outcomes\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eBoth groups demonstrated significant within-group improvements in quality of life from baseline to three months (both p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.001). The control group's mean global health status score increased from 53.29 to 68.02, representing a mean change of 14.73\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;15.63. In the intervention group, the score increased from 49.67 to 72.88, representing a greater mean change of 23.20\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;22.00. The between-group difference in change scores was statistically significant (p\\u0026thinsp;=\\u0026thinsp;0.032), favouring the intervention group (Table\\u0026nbsp;\\u003cspan refid=\\\"Tab3\\\" class=\\\"InternalRef\\\"\\u003e3\\u003c/span\\u003e).\\u003c/p\\u003e\\u003cp\\u003e\\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab3\\\" border=\\\"1\\\"\\u003e\\u003ccaption language=\\\"En\\\"\\u003e\\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 3\\u003c/div\\u003e\\u003cdiv class=\\\"CaptionContent\\\"\\u003e\\u003cp\\u003eQuality of Life and Symptom Scores by Group\\u003c/p\\u003e\\u003c/div\\u003e\\u003c/caption\\u003e\\u003ccolgroup cols=\\\"8\\\"\\u003e\\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c4\\\" colnum=\\\"4\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c5\\\" colnum=\\\"5\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c6\\\" colnum=\\\"6\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c7\\\" colnum=\\\"7\\\"\\u003e\\u003c/div\\u003e\\u003cdiv align=\\\"char\\\" char=\\\".\\\" class=\\\"colspec\\\" colname=\\\"c8\\\" colnum=\\\"8\\\"\\u003e\\u003c/div\\u003e\\u003cthead\\u003e\\u003ctr\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003eDomain\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eCategory\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colspan=\\\"3\\\" nameend=\\\"c5\\\" namest=\\\"c3\\\"\\u003e\\u003cp\\u003eIntervention Group\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colspan=\\\"3\\\" nameend=\\\"c8\\\" namest=\\\"c6\\\"\\u003e\\u003cp\\u003eControl Group\\u003c/p\\u003e\\u003c/th\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003eAt 3 Months\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003ep-value\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003eBaseline\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003eAt 3 Months\\u003c/p\\u003e\\u003c/th\\u003e\\u003cth align=\\\"left\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003ep-value\\u003c/p\\u003e\\u003c/th\\u003e\\u003c/tr\\u003e\\u003c/thead\\u003e\\u003ctbody\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eGlobal Health Status\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eGlobal Health Status\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e50.0 (33.3\\u0026ndash;66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e83.3 (66.6\\u0026ndash;83.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e50.0 (50.0-66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e66.6 (58.3\\u0026ndash;75.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\" morerows=\\\"4\\\" rowspan=\\\"5\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eFunctional Scales\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003ePhysical Functioning\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e66.6 (53.3\\u0026ndash;80.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e91.6 (80.0-93.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e80.0 (60.0-93.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e80.0 (80.0-86.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e0.036\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eRole Functioning\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e66.6 (33.3\\u0026ndash;83.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e66.6 (66.6\\u0026ndash;100)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e66.6 (50.0-83.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e66.6 (66.6\\u0026ndash;83.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e0.043\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eEmotional Functioning\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e50.0 (50.0\\u0026ndash;75.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e83.3 (83.3\\u0026ndash;100)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e58.3 (50.0\\u0026ndash;75.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e83.3 (75.0-83.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eCognitive Functioning\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e83.3 (66.6\\u0026ndash;100)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e100 (83.3\\u0026ndash;100)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e83.3 (66.6\\u0026ndash;100)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e83.3 (83.3\\u0026ndash;100)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e0.006\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eSocial Functioning\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e66.6 (33.3\\u0026ndash;66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e83.3 (66.6\\u0026ndash;100)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e66.6 (50.0-66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e50.0 (50.0-66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e0.287\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c1\\\" morerows=\\\"6\\\" rowspan=\\\"7\\\"\\u003e\\u003cp\\u003e\\u003cb\\u003eSymptom Scales\\u003c/b\\u003e\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eFatigue\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e33.3 (22.2\\u0026ndash;55.5)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e11.1 (0.0-22.2)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e22.2 (22.2\\u0026ndash;44.4)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e22.2 (22.2\\u0026ndash;33.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e0.007\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eNausea/Vomiting\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e0.0 (0.0-16.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0\\u0026ndash;0.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.015\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e0.0 (0.0-16.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e0.0 (0.0-16.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e0.200\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003ePain\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e50.0 (33.3\\u0026ndash;66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e16.6 (0.0-33.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e33.3 (33.3\\u0026ndash;50.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e16.6 (16.6\\u0026ndash;33.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eDyspnoea\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e0.0 (0.0-33.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0\\u0026ndash;0.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.000\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e0.0 (0.0\\u0026ndash;0.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e0.0 (0.0\\u0026ndash;0.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e0.004\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eInsomnia\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e33.3 (0.0-66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0\\u0026ndash;0.0)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.000\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e33.3 (0.0-66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e0.0 (0.0-33.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e\\u0026lt;\\u0026thinsp;0.001\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eAppetite Loss\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e33.3 (0.0-66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0-33.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.000\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e33.3 (33.3\\u0026ndash;66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e33.3 (33.3\\u0026ndash;33.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e0.005\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003ctr\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u003cp\\u003eFinancial Difficulties\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c3\\\"\\u003e\\u003cp\\u003e33.3 (33.3\\u0026ndash;66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c4\\\"\\u003e\\u003cp\\u003e0.0 (0.0-33.3)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c5\\\"\\u003e\\u003cp\\u003e0.000\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u003cp\\u003e33.3 (0.0-66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c7\\\"\\u003e\\u003cp\\u003e33.3 (33.3\\u0026ndash;66.6)\\u003c/p\\u003e\\u003c/td\\u003e\\u003ctd align=\\\"char\\\" char=\\\".\\\" colname=\\\"c8\\\"\\u003e\\u003cp\\u003e0.999\\u003c/p\\u003e\\u003c/td\\u003e\\u003c/tr\\u003e\\u003c/tbody\\u003e\\u003c/colgroup\\u003e\\u003c/table\\u003e\\u003c/div\\u003e\\u003c/p\\u003e\\u003cp\\u003e\\u003cem\\u003eData presented as median (interquartile range). P-values from Wilcoxon signed-rank tests for within-group changes.\\u003c/em\\u003e\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eSymptom Burden Reduction\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eBoth groups exhibited significant reductions in symptom burden from baseline to three months; however, improvements were substantially more pronounced in the intervention group. The mean reduction in the total ESAS score was 30.69\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;15.51 in the intervention group compared to 22.9\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;15.99 in the control group (p\\u0026thinsp;=\\u0026thinsp;0.014).\\u003c/p\\u003e\\u003cp\\u003eSpecific symptom improvements favoured the intervention group across multiple domains (Fig.\\u0026nbsp;\\u003cspan refid=\\\"Fig2\\\" class=\\\"InternalRef\\\"\\u003e2\\u003c/span\\u003e). The mean reduction in the pain score was 4.48\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;2.08 in the intervention group versus 3.1\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;2.31 in the control group (p\\u0026thinsp;=\\u0026thinsp;0.0075). Fatigue showed significant improvement in both groups, with a greater reduction in the intervention group (t-statistic\\u0026thinsp;=\\u0026thinsp;7.21, p\\u0026thinsp;=\\u0026thinsp;2.78 \\u0026times; 10⁻⁹) compared to controls (t-statistic\\u0026thinsp;=\\u0026thinsp;2.92, p\\u0026thinsp;=\\u0026thinsp;5.55 \\u0026times; 10⁻\\u0026sup3;). Sleep disturbance, depression, stress, and appetite loss all showed significantly greater improvements in the intervention group compared to the control group (all p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.001) (Table\\u0026nbsp;\\u003cspan refid=\\\"Tab2\\\" class=\\\"InternalRef\\\"\\u003e2\\u003c/span\\u003e).\\u003c/p\\u003e\\u003cp\\u003e\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eFunctional Status and Psychological Outcomes\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eECOG performance scores remained comparable between the groups at three months (p\\u0026thinsp;=\\u0026thinsp;0.452), indicating that both treatment approaches maintained functional status without significant differences between groups. Insomnia improved significantly in both groups; however, between-group comparisons revealed no statistically significant difference (p\\u0026thinsp;=\\u0026thinsp;0.921).\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eFinancial Burden and Healthcare Utilisation\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eThe intervention group experienced a significant reduction in financial burden with a mean change of -26.80 (SD\\u0026thinsp;=\\u0026thinsp;28.30) compared to no significant change in the control group (mean change: 0.00, SD\\u0026thinsp;=\\u0026thinsp;41.79, p\\u0026thinsp;=\\u0026thinsp;0.001). This represented a large effect size (Cohen's d\\u0026thinsp;=\\u0026thinsp;0.75) for reducing financial burden.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003ePatient and Caregiver Satisfaction\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003ePatient and caregiver satisfaction levels were significantly higher in the intervention group. The mean improvement in global health satisfaction scores was 23.20 (SD\\u0026thinsp;=\\u0026thinsp;22.00) in the intervention group compared to 14.73 (SD\\u0026thinsp;=\\u0026thinsp;15.63) in the control group (p\\u0026thinsp;=\\u0026thinsp;0.032).\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003ePredictive and Mediation Analyses\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eAge and ECOG status did not significantly influence treatment outcomes in subgroup analyses. Pain reduction emerged as a key predictor of quality of life improvements, with a strong positive correlation (r\\u0026thinsp;=\\u0026thinsp;0.52, p\\u0026thinsp;=\\u0026thinsp;0.002). Regression analysis confirmed that pain reduction accounted for 28.9% of the variance in quality of life improvements (R\\u0026sup2; = 0.289). Mediation analysis revealed that a one-point decrease in pain resulted in a 0.46-point increase in global health scores, confirmed by the Sobel test (p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.001) (Fig.\\u0026nbsp;\\u003cspan refid=\\\"Fig3\\\" class=\\\"InternalRef\\\"\\u003e3\\u003c/span\\u003e)\\u003c/p\\u003e\\u003cp\\u003e\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eEffect Size Analysis\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eEffect size analysis demonstrated varying impacts of the intervention across different domains. Fatigue reduction showed a moderate effect size (Cohen's d\\u0026thinsp;=\\u0026thinsp;0.55), while pain reduction demonstrated a small to moderate effect (Cohen's d\\u0026thinsp;=\\u0026thinsp;0.38). Financial burden reduction exhibited the largest effect size (Cohen's d\\u0026thinsp;=\\u0026thinsp;0.75), indicating substantial clinical significance of the economic benefits associated with early supportive care.\\u003c/p\\u003e\"},{\"header\":\"Discussion\",\"content\":\"\\u003cp\\u003eThe integration of early supportive care into oncology treatment paradigms has increasingly been recognised as a vital approach for addressing the multifactorial needs of patients with advanced cancer. Our study provides evidence that early supportive care, when initiated alongside standard oncologic treatment, yields substantial benefits across multiple domains, including symptom control, quality of life, psychological well-being, financial burden, and overall patient satisfaction.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eSymptom Control and Quality of Life\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eA key strength of our study lies in the significant reduction of symptom burden achieved in the intervention group across nearly all domains assessed by the Edmonton Symptom Assessment Scale. Patients receiving early supportive care reported pronounced improvements in pain, fatigue, sleep disturbance, depression, appetite loss, and overall well-being. These findings align with those of Bandieri et al., who demonstrated meaningful symptom relief in patients with advanced cancer following early palliative care. However, between-group differences were sometimes less pronounced than observed in our study [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e].\\u003c/p\\u003e\\u003cp\\u003eThe landmark trial by Temel et al. found that patients with non-small-cell lung cancer who received early palliative care experienced significantly reduced symptom severity and improved mood compared to those receiving standard care alone [\\u003cspan citationid=\\\"CR8\\\" class=\\\"CitationRef\\\"\\u003e8\\u003c/span\\u003e]. Our findings echo these results, particularly in the domains of fatigue and psychological stress, reinforcing the notion that early supportive interventions enhance both physical and emotional well-being.\\u003c/p\\u003e\\u003cp\\u003e Both the intervention and control groups in our study exhibited significant within-group improvements in quality of life; however, the supportive care group demonstrated significantly greater improvement in change scores. This finding aligns with the results of Greer et al., who reported quality of life improvements in patients receiving early palliative care [\\u003cspan citationid=\\\"CR12\\\" class=\\\"CitationRef\\\"\\u003e12\\u003c/span\\u003e]. The PACO trial by Allende et al. found that early integration of palliative care in NSCLC patients significantly improved both quality of life and survival, with benefits more pronounced in individuals with higher baseline scores, suggesting that earlier initiation may be key to maximising effectiveness [\\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e].\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eEconomic Impact\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eOne of the most novel aspects of our study is the significant reduction in financial burden experienced by patients in the intervention group. While economic outcomes are often underreported in supportive care trials, our findings demonstrate that early supportive care can substantially alleviate the financial toxicity associated with cancer treatment. The intervention group reported a marked decrease in financial distress, whereas the control group showed no change, highlighting the role of comprehensive supportive care in mitigating indirect treatment burdens.\\u003c/p\\u003e\\u003cp\\u003eThis observation is supported by Greer et al., who reported that early palliative care led to lower average healthcare expenditures, particularly through decreased chemotherapy use in the final stages of life [\\u003cspan citationid=\\\"CR12\\\" class=\\\"CitationRef\\\"\\u003e12\\u003c/span\\u003e]. The American Society of Clinical Oncology has formally recognised the cost-saving potential of early palliative integration, advocating for early combination of palliative and standard oncologic care as a strategy to enhance patient outcomes while reducing resource-intensive interventions [\\u003cspan citationid=\\\"CR14\\\" class=\\\"CitationRef\\\"\\u003e14\\u003c/span\\u003e].\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003ePsychological and Functional Outcomes\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003ePatients in the intervention group exhibited greater reductions in fatigue, depression, and stress compared to those receiving standard care. These results are consistent with findings from Datta et al., who observed improved emotional well-being among lung cancer patients receiving early integrated palliative care in India [\\u003cspan citationid=\\\"CR15\\\" class=\\\"CitationRef\\\"\\u003e15\\u003c/span\\u003e]. Despite improvements in symptom burden and emotional well-being, our study found no significant differences in ECOG performance status between groups, suggesting that while early supportive care enhances subjective well-being, its impact on objective functional measures may require longer evaluation periods.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eMechanistic Insights\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eThrough mediation analysis, we demonstrated that pain reduction was a significant predictor of quality of life improvement, explaining nearly 29% of the variance in global health outcomes. This finding enhances our understanding of the pathways through which early supportive care achieves benefits and underscores the importance of proactively addressing specific symptom domains. The strong correlation between pain management and overall quality of life improvements suggests that targeted symptom control may be a key mechanism underlying the broader benefits of comprehensive supportive care.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eStudy Limitations\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eSeveral limitations warrant consideration. The reduced sample size (110 versus the planned 270 patients) due to COVID-19 pandemic restrictions may have limited statistical power to detect smaller effect sizes, although significant effects were observed across key outcomes. The single-centre design may limit generalizability to other healthcare settings. The inability to blind participants and care providers due to the nature of interventions may have introduced bias, although independent outcome assessors were used to minimise this limitation. Additionally, the three-month follow-up period may not capture long-term benefits or the sustainability of the intervention effects.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eClinical Implications\\u003c/b\\u003e\\u003c/p\\u003e\\u003cp\\u003eOur findings support the integration of early supportive care as a standard component of breast cancer management, particularly in resource-limited settings. The significant improvements in symptom control, quality of life, and financial burden, combined with high patient satisfaction, provide compelling evidence for the routine implementation of this approach. The intervention's effectiveness across multiple domains suggests that early supportive care should not be viewed as an optional addition but rather as an integral component of comprehensive cancer care.\\u003c/p\\u003e\"},{\"header\":\"Conclusion\",\"content\":\"\\u003cp\\u003eThe findings of this study strongly support the integration of early supportive care in the management of breast cancer. The intervention significantly reduced symptom burden\\u0026mdash;particularly pain, fatigue, depression, and stress\\u0026mdash;while also improving quality of life and alleviating financial strain. Additionally, patient and caregiver satisfaction were notably higher in the intervention group, reinforcing the clinical benefits of early supportive care. Early integration of supportive care significantly reduces symptom burden, enhances psychological well-being, and lowers financial stress in breast cancer patients, supporting its inclusion as a standard adjunct to cancer care in developing countries.\\u003c/p\\u003e\"},{\"header\":\"Declarations\",\"content\":\"\\u003cp\\u003e\\u003cstrong\\u003eFunding\\u003c/strong\\u003e The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eCompeting Interests:\\u003c/strong\\u003e The authors have no relevant financial or non-financial interests to disclose.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eEthics Approval\\u003c/strong\\u003e: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Institutional Ethics Committee of the All India Institute of Medical Sciences, New Delhi (No. IECPG-207/24.03.2021, RT -03/28.05.2021)..\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConsent to Participate:\\u003c/strong\\u003e Informed consent was obtained from all individual participants included in the study.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConsent to Publish\\u003c/strong\\u003e: Not applicable.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eData Availability\\u003c/strong\\u003e: The datasets generated and analysed during the current study are available as a supplementary material.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAuthor Contributions\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eN.G., A.B., and H.V. conceptualized the study. N.G., A.B., R.K.M., and H.V. developed the methodology. H.V. and P.M. prepared the original draft. N.G., A.B., A.G., B.K.R., V.K., R.K.M., S.J.B. reviewed and edited the manuscript. S.B., S.M., R.G., and S.J.B. supervised the work. All authors read and approved the final manuscript.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAcknowledgements\\u003c/strong\\u003e The authors would like to acknowledge the following individuals for their support and contributions:\\u003c/p\\u003e\\n\\u003cul type=\\\"disc\\\"\\u003e\\n \\u003cli\\u003eDr. Saurabh Vig, Dr. Anuja Pandit, Dr. Shweta Bhopale, Dr. Balbir Kumar (Associate professor, Onco-Anesthesia \\u0026amp; Palliative Medicine, NCI-Jhajjar, AIIMS, New Delhi)\\u003c/li\\u003e\\n \\u003cli\\u003eDr. Prashant Sirohiya, Dr. Raghav Gupta, Dr. Bhanu Pratap Maurya, Dr. Puneet Rathore (Assistant professor, Onco-Anesthesia \\u0026amp; Palliative Medicine, NCI-Jhajjar, AIIMS, New Delhi)\\u003c/li\\u003e\\n \\u003cli\\u003eDr. Vikram Pratap Singh (Assistant professor, Palliative Medicine, Delhi State Cancer Hospital, New Delhi)\\u003c/li\\u003e\\n\\u003c/ul\\u003e\"},{\"header\":\"References\",\"content\":\"\\u003col\\u003e\\u003cli\\u003e\\u003cspan\\u003eSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA A Cancer J Clinicians 2021;71:209\\u0026ndash;49.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eMalvia S, Bagadi SA, Dubey US, Saxena S. Epidemiology of breast cancer in Indian women. Asia-Pacific Journal of Clinical Oncology 2017;13.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eMathur P, Sathishkumar K, Chaturvedi M, Das P, Sudarshan K, Santhappan S, et al. Cancer Statistics, 2020: Report From National Cancer Registry Programme, India. JCO Global Oncology 2020;6.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eMedina J de MR, Trugilho I de A, Mendes GNB, Silva JG, Paiva MA da S, Aguiar SS de, et al. Advanced Clinical Stage at Diagnosis of Breast Cancer Is Associated with Poorer Health-Related Quality of Life: A Cross-Sectional Study. European Journal of Breast Health 2019;15:26\\u0026ndash;31.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eLima E, Silva M. Quality of life of women with locally advanced or metastatic breast cancer. Revista Gaucha de Enfermagem 2020;41.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eJanz NK, Friese CR, Li Y, Graff JJ, Hamilton AS, Hawley ST. Emotional well-being years post-treatment for breast cancer: prospective, multi-ethnic, and population-based analysis. J Cancer Surviv 2014;8:131\\u0026ndash;42.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eLigt KMD, Heins M, Verloop J, Ezendam N, Smorenburg C, Korevaar J, et al. The impact of health symptoms on health-related quality of life in early-stage breast cancer survivors. Breast Cancer Research and Treatment 2019;178:703\\u0026ndash;11.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eTemel J, Greer J, Muzikansky A, Gallagher E, Admane S, Jackson V, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. The New England Journal of Medicine 2010;363:733\\u0026ndash;42.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eZimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, et al. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. The Lancet 2014;383:1721\\u0026ndash;30.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eBandieri E, Banchelli F, Artioli F, Mucciarini C, Razzini G, Cruciani M, et al. Early versus delayed palliative/supportive care in advanced cancer: an observational study. BMJ Supportive \\u0026amp; Palliative Care 2019;10:32\\u0026ndash;32.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eVanbutsele G, Van Belle S, Surmont V, De Laat M, Colman R, Eecloo K, et al. The effect of early and systematic integration of palliative care in oncology on quality of life and health care use near the end of life: A randomised controlled trial. European Journal of Cancer 2020;124:186\\u0026ndash;93. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1016/j.ejca.2019.11.009\\u003c/span\\u003e\\u003cspan address=\\\"10.1016/j.ejca.2019.11.009\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eGreer JA, Tramontano A, McMahon PM, El-Jawahri A, Parikh RB, Gallagher ER, et al. Cost analysis of a randomized trial of early palliative care (PC) in patients with metastatic non-small cell lung cancer (NSCLC). JCO 2014;32:4\\u0026ndash;4.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eAllende S, Turcott JG, Ver\\u0026aacute;stegui E, Rodr\\u0026iacute;guez-Mayoral O, Flores-Estrada D, P\\u0026eacute;rez Camargo DA, et al. Early Incorporation to Palliative Care (EPC) in Patients With Advanced Non-Small Cell Lung Cancer: The PACO Randomized Clinical Trial. The Oncologist 2024;29:e1373\\u0026ndash;85.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eSmith TJ, Temin S, Alesi ER, Abernethy AP, Balboni TA, Basch EM, et al. American Society of Clinical Oncology Provisional Clinical Opinion: The Integration of Palliative Care Into Standard Oncology Care. JCO 2012;30:880\\u0026ndash;7.\\u003c/span\\u003e\\u003c/li\\u003e\\u003cli\\u003e\\u003cspan\\u003eDatta A, Ostwal S, Das A. Role of Symptomatic Management in Understanding Effects of Early Integration of Palliative Care among Nonmetastatic Lung Cancer Patients on Psychological Well-Being. European Journal of Cancer Care 2024.\\u003c/span\\u003e\\u003c/li\\u003e\\u003c/ol\\u003e\"}],\"fulltextSource\":\"\",\"fullText\":\"\",\"funders\":[],\"hasAdminPriorityOnWorkflow\":false,\"hasManuscriptDocX\":true,\"hasOptedInToPreprint\":true,\"hasPassedJournalQc\":\"\",\"hasAnyPriority\":false,\"hideJournal\":false,\"highlight\":\"\",\"institution\":\"\",\"isAcceptedByJournal\":true,\"isAuthorSuppliedPdf\":false,\"isDeskRejected\":\"\",\"isHiddenFromSearch\":false,\"isInQc\":false,\"isInWorkflow\":false,\"isPdf\":false,\"isPdfUpToDate\":true,\"isWithdrawnOrRetracted\":false,\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"supportive-care-in-cancer\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":false,\"externalIdentity\":\"jscc\",\"sideBox\":\"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)\",\"snPcode\":\"520\",\"submissionUrl\":\"https://submission.nature.com/new-submission/520/3\",\"title\":\"Supportive Care in Cancer\",\"twitterHandle\":\"\",\"acdcEnabled\":true,\"dfaEnabled\":true,\"editorialSystem\":\"stoa\",\"reportingPortfolio\":\"Springer Hybrid\",\"inReviewEnabled\":true,\"inReviewRevisionsEnabled\":false},\"keywords\":\"Breast Cancer, Supportive Care, Quality of Life, Symptom Burden, Palliative Oncology, EORTC QLQ-C30, ESAS, India, Pain Management\",\"lastPublishedDoi\":\"10.21203/rs.3.rs-7195177/v1\",\"lastPublishedDoiUrl\":\"https://doi.org/10.21203/rs.3.rs-7195177/v1\",\"license\":{\"name\":\"CC BY 4.0\",\"url\":\"https://creativecommons.org/licenses/by/4.0/\"},\"manuscriptAbstract\":\"\\u003ch2\\u003ePurpose\\u003c/h2\\u003e\\u003cp\\u003eBreast cancer is the most common malignancy among women in India, with a significant proportion diagnosed at advanced stages. These patients often endure a high symptom burden and compromised quality of life (QoL). Early integration of supportive care may improve outcomes, yet remains underutilised in resource-limited settings. This study evaluated the effect of early integration of supportive care alongside standard oncology treatment on QoL and symptom burden in breast cancer patients.\\u003c/p\\u003e\\u003ch2\\u003eMethods\\u003c/h2\\u003e\\u003cp\\u003eIn this single-centre, randomised controlled trial, 110 newly diagnosed adult female breast cancer patients were randomised (1:1) into an intervention group (early supportive care and standard care) or control group (standard care only). Supportive care included symptom management, psychosocial counselling, and educational support. Outcomes were assessed at baseline and 3 months using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Edmonton Symptom Assessment Scale (ESAS). Statistical analyses included t-tests, multivariate regression, and mediation modelling.\\u003c/p\\u003e\\u003ch2\\u003eResults\\u003c/h2\\u003e\\u003cp\\u003eBoth groups showed significant improvement in QoL, but greater symptom reduction was observed in the intervention group (mean\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;SD ESAS reduction: 30.69\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;15.51 vs. 22.9\\u0026thinsp;\\u0026plusmn;\\u0026thinsp;15.99; p\\u0026thinsp;=\\u0026thinsp;0.014). Fatigue and pain were significantly lower in the supportive care group (Cohen's d\\u0026thinsp;=\\u0026thinsp;0.55 and 0.38, respectively). The financial burden was also significantly reduced (p\\u0026thinsp;=\\u0026thinsp;0.001), accompanied by higher patient and caregiver satisfaction scores (p\\u0026thinsp;=\\u0026thinsp;0.032). Mediation analysis confirmed pain reduction as a key predictor of QoL improvement (p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.001).\\u003c/p\\u003e\\u003ch2\\u003eConclusions\\u003c/h2\\u003e\\u003cp\\u003eEarly integration of supportive care significantly reduces symptom burden, enhances psychological well-being, and lowers financial stress in breast cancer patients, supporting its inclusion as a standard adjunct to cancer care in developing countries.\\u003c/p\\u003e\\u003ch2\\u003eTrial Registration\\u003c/h2\\u003e\\u003cp\\u003eCTRI/2021/06/034136, Date 10/06/2021\\u003c/p\\u003e\",\"manuscriptTitle\":\"Effect of Early Integration of Supportive Care in Addition to Standard Care in Patients with Breast Cancer: A Randomised Controlled Trial\",\"msid\":\"\",\"msnumber\":\"\",\"nonDraftVersions\":[{\"code\":1,\"date\":\"2025-09-03 23:56:54\",\"doi\":\"10.21203/rs.3.rs-7195177/v1\",\"editorialEvents\":[{\"type\":\"communityComments\",\"content\":0},{\"type\":\"decision\",\"content\":\"Revision requested\",\"date\":\"2025-10-20T17:18:00+00:00\",\"index\":\"\",\"fulltext\":\"\"},{\"type\":\"editorInvitedReview\",\"content\":\"\",\"date\":\"2025-10-20T12:18:19+00:00\",\"index\":\"hide\",\"fulltext\":\"\"},{\"type\":\"editorInvitedReview\",\"content\":\"\",\"date\":\"2025-10-11T14:20:50+00:00\",\"index\":\"hide\",\"fulltext\":\"\"},{\"type\":\"reviewerAgreed\",\"content\":\"122842612136396281066843681387159683825\",\"date\":\"2025-09-30T19:40:37+00:00\",\"index\":\"hide\",\"fulltext\":\"\"},{\"type\":\"reviewerAgreed\",\"content\":\"270063600823733676252366585200309494835\",\"date\":\"2025-09-19T11:29:12+00:00\",\"index\":\"hide\",\"fulltext\":\"\"},{\"type\":\"reviewersInvited\",\"content\":\"\",\"date\":\"2025-08-26T19:03:55+00:00\",\"index\":\"\",\"fulltext\":\"\"},{\"type\":\"editorAssigned\",\"content\":\"\",\"date\":\"2025-08-26T19:02:54+00:00\",\"index\":\"\",\"fulltext\":\"\"},{\"type\":\"checksComplete\",\"content\":\"\",\"date\":\"2025-07-29T02:20:47+00:00\",\"index\":\"\",\"fulltext\":\"\"},{\"type\":\"submitted\",\"content\":\"Supportive Care in Cancer\",\"date\":\"2025-07-23T10:10:35+00:00\",\"index\":\"\",\"fulltext\":\"\"}],\"status\":\"published\",\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"supportive-care-in-cancer\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":false,\"externalIdentity\":\"jscc\",\"sideBox\":\"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)\",\"snPcode\":\"520\",\"submissionUrl\":\"https://submission.nature.com/new-submission/520/3\",\"title\":\"Supportive Care in Cancer\",\"twitterHandle\":\"\",\"acdcEnabled\":true,\"dfaEnabled\":true,\"editorialSystem\":\"stoa\",\"reportingPortfolio\":\"Springer Hybrid\",\"inReviewEnabled\":true,\"inReviewRevisionsEnabled\":false}}],\"origin\":\"\",\"ownerIdentity\":\"4381f268-9143-4e34-892f-2563f283ab69\",\"owner\":[],\"postedDate\":\"September 3rd, 2025\",\"published\":true,\"recentEditorialEvents\":[],\"rejectedJournal\":[],\"revision\":\"\",\"amendment\":\"\",\"status\":\"published-in-journal\",\"subjectAreas\":[],\"tags\":[],\"updatedAt\":\"2026-02-09T16:03:25+00:00\",\"versionOfRecord\":{\"articleIdentity\":\"rs-7195177\",\"link\":\"https://doi.org/10.1007/s00520-026-10401-x\",\"journal\":{\"identity\":\"supportive-care-in-cancer\",\"isVorOnly\":false,\"title\":\"Supportive Care in Cancer\"},\"publishedOn\":\"2026-02-02 15:59:16\",\"publishedOnDateReadable\":\"February 2nd, 2026\"},\"versionCreatedAt\":\"2025-09-03 23:56:54\",\"video\":\"\",\"vorDoi\":\"10.1007/s00520-026-10401-x\",\"vorDoiUrl\":\"https://doi.org/10.1007/s00520-026-10401-x\",\"workflowStages\":[]},\"version\":\"v1\",\"identity\":\"rs-7195177\",\"journalConfig\":\"researchsquare\"},\"__N_SSP\":true},\"page\":\"/article/[identity]/[[...version]]\",\"query\":{\"redirect\":\"/article/rs-7195177\",\"identity\":\"rs-7195177\",\"version\":[\"v1\"]},\"buildId\":\"8U1c8b4HqxoKbykW_rLl7\",\"isFallback\":false,\"isExperimentalCompile\":false,\"dynamicIds\":[84888],\"gssp\":true,\"scriptLoader\":[]}","source_license":"CC-BY-4.0","license_restricted":false}