Feasibility Study of the Four-Session Cognitive-Behavioral Therapy–based Psychological Intervention Program for Women with HER2-Positive Metastatic Breast Cancer

Feasibility Study of the Four-Session Cognitive-Behavioral Therapy–based Psychological Intervention Program for Women with HER2-Positive Metastatic Breast Cancer | 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 Feasibility Study of the Four-Session Cognitive-Behavioral Therapy–based Psychological Intervention Program for Women with HER2-Positive Metastatic Breast Cancer Tamás Szekeres, Máté Ádám Balázs, Bálint Madarász, Zsuzsa Póti, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8595208/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Purpose Although targeted therapies have prolonged survival in HER2-positive metastatic breast cancer, the resulting chronic disease trajectory is frequently accompanied by substantial psychological burden. This study aimed to conduct a preliminary investigation into the feasibility and psychological outcomes of a low-intensity, group-based cognitive-behavioral therapy intervention (CBT-OP-4) among women receiving palliative care. Methods A prospective feasibility study was undertaken involving 13 female participants (Mean age = 63 years, SD = 8.05), all diagnosed with HER2-positive metastatic breast cancer. The four-session CBT-based group intervention targeted key psychological domains. Self-reported measures of distress, depression, anxiety, perceived stigma, self-compassion, and locus of control were administered pre- and post-intervention. Feasibility and acceptability were further examined via semi-structured qualitative interviews and standardized patient satisfaction instruments. Results Following the intervention, statistically significant pre–post reductions were observed in psychological distress, depressive symptoms, and perceived stigma. In parallel, participants demonstrated a significant increase in self-compassion. Overall, the program was rated as highly acceptable, with participants emphasizing the relevance and applicability of the intervention content within their illness context. Conclusion Findings from this preliminary study suggest that the CBT-OP-4 program is a feasible and acceptable psycho-oncological intervention for women with advanced-stage HER2-positive breast cancer receiving palliative care. The results offer initial empirical support for the incorporation of structured, evidence-based psychological interventions into the routine psychosocial management of this patient population HER2-positive breast cancer low-intensity psychological intervention palliative care psycho-oncology cognitive-behavioral therapy distress Figures Figure 1 Introduction Breast cancer remains the most commonly diagnosed malignancy among women worldwide [ 1 ]. The classification of breast cancer subtypes - such as luminal A, luminal B, human epidermal growth factor receptor 2 (HER2) -positive, and basal-like—is essential for developing personalized treatment strategies, as each subtype is associated with distinct prognoses and therapeutic responses [ 2 ]. The HER2-positive subtype accounts for approximately 15–20% of cases and is characterized by aggressive clinical behavior, rapid progression, and a higher recurrence rate [ 3 ]. Although HER2-targeted therapies (e.g., trastuzumab, pertuzumab) have significantly improved patient outcomes, in metastatic settings the disease remains a chronic, incurable condition that requires complex treatment and a multidisciplinary care approach [ 4 ]. Despite the survival benefits achieved with anti-HER2 targeted therapies in patients with metastatic disease, the psychosocial burden during the chronic, non-curative phase remains substantial [ 5 ]. These patients typically undergo continuous maintenance therapy, resulting in ongoing exposure to treatment-related side effects such as cardiotoxicity, altered immune response, gastrointestinal disturbances, and dermatological or hair-related issues [ 6 ]. Moreover, research has shown that a diagnosis of metastatic disease is frequently associated with elevated levels of psychological distress, depressive and anxiety symptoms, and perceived stigma [ 6 , 7 ]. These psychological burdens negatively impact quality of life, may compromise treatment adherence, and can ultimately reduce overall survival [ 8 ]. In palliative care, there is an increasingly recognized need for integrated psychological interventions, a demand supported by the growing body of meta-analytic evidence demonstrating their positive effects on psychological outcomes [ 9 ]. Evidence-based psychotherapeutic approaches such as cognitive-behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), self-compassion training, and positive psychology interventions have shown effectiveness in reducing psychological distress, depression, anxiety, and perceived stigma. These approaches also contribute to improved quality of life, enhanced coping skills, and, in some cases, better adherence and survival outcomes [ 10 – 14 ]. Although comprehensive CBT-based programs have been developed to improve quality of life and treatment adherence among oncology patients [ 15 ], no such integrated program has been specifically tailored to the psychological needs of patients with HER2-positive metastatic breast cancer receiving palliative care (e.g., trastuzumab, pertuzumab). To date, there has been no comprehensive intervention that incorporates evidence-based psychotherapeutic tools adapted to the complex psychosocial context of this patient population. The aim of the present study is to provide a brief overview of a comprehensive, low-intensity, group-based cognitive-behavioral therapy intervention (Four-Session Cognitive-Behavioral Therapy–based Psychological Intervention Program for Oncological Patients; CBT-OP-4), specifically developed for women with HER2-positive metastatic breast cancer receiving palliative care. In addition, the study seeks to assess the feasibility and report preliminary outcomes concerning the intervention’s effectiveness. Methods Sample and procedure The prospective feasibility study was conducted within an investigator initiated academic study (IIS) - titled “ Value-based health economic comparative study of subcutaneous and intravenous pertuzumab-trastuzumab for HER2 positive metastatic breast cancer based on patient reported outcomes.” - in 2023–2025. The overall study was to perform value-based health economic comparison of subcutaneous and intravenous pertuzumab-trastuzumab for HER2 positive metastatic breast cancer based on patient reported outcomes. Furthermore, a comprehensive onco-rehabilitation program was involved in this academic study, such as a peer-to-peer support program conducted by patient organization, nutritional therapy intervention, and a brief, comprehensive CBT-based psychological support program (Four-Session Cognitive-Behavioral Therapy–based Psychological Intervention Program for Oncological Patients, CBT-OP-4). The full study protocol is illustrated in Fig. 1 . Participants were recruited from multiple oncology centers in Hungary. A total of 23 patients participated in the study, including 16 from the Oncology Profile of the Department of Internal Medicine and Oncology at Semmelweis University, 5 from Uzsoki Street Hospital, 1 from the University of Debrecen, and 1 from the South-Pest Central Hospital. The intervention group (n = 13) consisted of participants from the University of Debrecen (n = 1), Uzsoki Street Hospital (n = 2), and Semmelweis University (n = 10). The study sample consisted of patients enrolled in the IIS; sampling was voluntary and based on strict inclusion and exclusion criteria. The inclusion and exclusion criteria of the overall study also applied to the CBT-OP-4 psychological support program. The following inclusion criteria were required: written informed consent from the patient; the patient had to finish induction therapy with pertuzumab and trastuzumab with chemotherapy for breast cancer; age of at least 18 years at the time of enrollment; confirmed HER2-positive, locally advanced, unresectable or metastatic breast cancer, confirmed by imaging and histopathological examination, irrespective of hormone receptor status; Ability to comply with the study protocol; Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; good patient adherence; baseline left ventricular ejection fraction (LVEF) of at least 50% measured by echocardiography; no contraindications of pertuzumab and trastuzumab treatment; and an expected survival exceeding six months. Patients were excluded from the study if they met any of the following exclusion criteria: use of a port catheter for intravenous drug administration; age above 75 years; early-stage breast cancer without confirmed local or distant metastases; progression during pertuzumab and trastuzumab therapy; pregnancy and/or breastfeeding; severe cardiovascular comorbidities, especially New York Heart Association (NYHA) functional class II–IV; pregnancy or lactation; presence of severe psychiatric disorders; current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders); inadequate bone marrow function; impaired liver function; and impaired renal function (serum creatinine > 1.5 × upper limit of normal). Any medical condition or laboratory abnormality that, in the investigator’s judgment, would jeopardize the patient’s safe participation in the study also led to exclusion. Additionally, patients with active liver disease (e.g., hepatitis B or C infection, autoimmune hepatitis, sclerosing cholangitis), concurrent severe uncontrolled infections, known HIV infection, or known hypersensitivity to the investigational drugs, excipients, or murine-derived proteins; were excluded. Table 1 presents the descriptive statistics of the study sample. The study has been registered in the European Medicines Agency (EMA) clinical trials database under the EudraCT number 2023-000156-38. The study protocol number is 20230123SE. Hungarian Health Authority approved and granted. Table 1 Demographics and disease-related information Variable Frequency/mean (SD) Age 63 (8.05) Relationship status Widowed Divorced Married In a relationship 3 (23%) 2 (15%) 6 (47%) 2 (23%) Place of residence Capital city Village Town / City 5 (38%) 2 (15%) 6 (47%) Educational attainment Elementary school Vocational school / Technical school High school Bachelor’s degree (BSc) Master’s degree (MSc) 1 (8%) 1 (8%) 3 (23%) 7 (53%) 1 (8%) Number of years since diagnosis 10,61 (6,87) Elapsed time (in years) since the diagnosis of metastatic disease 7,38 (5,59) Hormone receptor status Estrogen receptor (ER) positive Hormone receptor negative 4 (31%) 9 (69%) Site(s) of metastasis Skin Bone Bone and lymph nodes Bone and liver Liver and lung Lymph nodes and brain Lymph nodes Lung 1 (8%) 3 (23%) 2 (15%) 2 (15%) 1 (8%) 1 (8%) 2 (15%) 1 (8%) Ethics The study was conducted in accordance with the latest version of the Declaration of Helsinki and complied with applicable Good Clinical Practice (GCP) guidelines. Ethical approval for the research was granted by the Medical Research Council – Ethics Committee for Clinical Pharmacology (MRC ECCP - ETT KFEB), under the reference number BM/6420-0/2023-EKL. Interventions (Four-Session Cognitive-Behavioral Therapy–based Psychological Intervention Program for Oncological Patients, CBT-OP-4) Participants took part in a four-week, low-intensity, group-based cognitive-behavioral therapy intervention consisting of four sessions. Each session lasted 120 minutes and was facilitated by a cognitive-behavioral therapy (CBT) trained therapist alongside a clinical psychologist with specialized training in CBT. The intervention was based on the CBT – based psychological intervention program for Oncological Patients (CBT-OP), developed by Vizin [ 16 ]. This program was originally designed to reduce psychological symptoms related to cancer and its treatments, and to enhance treatment adherence, specifically for women with Grade I–III breast cancer. The original program consists of ten group sessions, with core components including cognitive restructuring, behavioral activation, problem-solving, education and psychoeducation, as well as mindfulness and self-compassion meditation. We adapted this program for use with women receiving palliative care. At the beginning of the program, participants received a workbook containing diaries, psychoeducational materials, and related worksheets. Each session commenced with a review of the home practice diaries. Every session included psychoeducational components, psychological intervention elements, home practice assignments, and group discussions related to these activities. Participants were sent reminder emails on the day following each session, which included materials for the week’s exercises. Sessions concluded with brief mindfulness and self-compassion meditation practices. The CBT-OP-4 program was structured as follows (Table 2 .): Table 2 Structure of the Four-Session Cognitive-behavioral Therapy - based psychological intervention program for Oncological Patients (CBT-OP-4) Session Topic Intervention Psychological assessment Assessed domains: depression, anxiety, distress, problem checklist, levels of stigmatization and shame, and self-compassion. Distress Thermometer, PHQ-4, SSCI-8, PCS, MHLC-C, SCS-SF First session Psychoeducation, emotion validation, cognitive model cognitive conceptualization, Three-column reflective journal Second session Depression and anxiety education, behavioral activation List of pleasant activities, mood diary Third session Assertiveness, resilience Assertiveness training, resilience exercise [ 34 ], gratitude journal Fourth session Crisis, coping, problem solving Psychoeducation on the cognitive model of coping with cancer, problem-solving worksheet Mindfulness and self-compassion practice at the end of each session Psychological assessment Assessed domains: depression, anxiety, distress and problem checklist, levels of stigmatization and shame, self-compassion Distress Thermometer, PHQ-4, SSCI-8, PCS, MHLC-C, SCS-SF Feasibility Evaluation of the program’s effectiveness and relevance Semi-structured interview Note. PHQ4 : Four-item patient health questionnaire; MHLC : Multidimensional Health Locus of Control Scales. SCS: Self-Compassion Scale. SSCI-8 : Stigma Scale for Chronic Illnesses questionnaire. Participants’ psychological status was assessed at two time points: prior to the intervention (baseline) and post-intervention. Validated self-administered questionnaires were employed to measure the psychological effects. Measures Demographic and disease-related data Data collection on demographic and disease-specific variables included age, relationship status, educational attainment, type of residence, date of initial breast cancer diagnosis, date of metastatic breast cancer diagnosis, hormone receptor status, and sites of metastasis. Distress Thermometer [ 17 ]: To measure psychological distress, the Distress Thermometer was employed, which is a single-item, 11-point visual analog scale ranging from 0 to 10. A score of 0 indicates no distress, while 10 represents the highest level of distress. Participants rated the level of distress they experienced over the past week, including the current day, by selecting a number on the scale. Complementing the scale is a 40-item problem checklist designed to identify sources of distress across six thematic categories: practical, family, emotional, spiritual/religious, physical, and other problems. Respondents indicated "yes" or "no" for each item depending on whether they experienced the specific problem during the past week. Four-item patient health questionnaire for anxiety and depression (PHQ-4) [ 18 ] The PHQ-4 is an ultrabrief, four-item self-administered psychological screening tool designed to rapidly detect symptoms of depression and anxiety. The questionnaire combines the Generalized Anxiety Disorder-2 (GAD-2) and the Patient Health Questionnaire-2 (PHQ-2), each comprising two items that measure symptoms of anxiety and depression, respectively [ 18 ]. Responses are given on a four-point Likert scale (0–3), reflecting symptom frequency over the past two weeks. The total score ranges from 0 to 12 and indicates the overall level of psychological distress, while subscale scores for anxiety and depression can be evaluated separately. The PHQ-4 demonstrates excellent psychometric properties and has been validated across various clinical and non-clinical populations, including oncology patients. The scale exhibits high sensitivity and specificity, making it particularly suitable for low-intensity settings and somatically burdened, older populations. Stigma Scale for Chronic Illnesses questionnaire (SSCI-8) [ 19 , 20 ] To assess stigmatization, the 8-item Stigma Scale for Chronic Illnesses (SSCI-8); was utilized. The questionnaire consists of eight items, making it suitable for use in clinical settings [ 20 ]. Participants rate statements such as “I felt embarrassed about my illness” and “Some people treated me as if it was my fault that I have this illness” on a 4-point Likert scale (1 = never, 4 = always). Scores range from 8 to 40, with higher scores indicating greater perceived stigmatization [ 20 ]. The instrument has demonstrated validity and reliability, with a Cronbach’s alpha of 0.89 [ 19 ]. Among samples of women with breast cancer, it has shown good test–retest reliability (r = 0.78) and internal consistency (Cronbach’s alpha = 0.89) [ 21 ]. Form C of the Multidimensional Health Locus of Control Scales questionnaire (MHLC-C) [ 22 – 24 ]: To assess health-related locus of control, the Hungarian version of the Multidimensional Health Locus of Control (MHLC) Form C questionnaire was utilized [ 24 ]. This instrument is specifically designed to evaluate the health locus of control among individuals living with chronic illnesses. The questionnaire comprises three subscales: internal control, external control (chance or luck), and social control. It contains no reverse-scored items. Individuals perceiving a high level of internal control believe they actively influence their own health. When the “chance” factor predominates, the course of the illness appears more unpredictable to the respondent. External control is characterized by a belief that the outcome of the illness is primarily determined by physicians or other significant individuals whom the person trusts. Self-compassion was assessed using the Hungarian adaptation of the Self-Compassion Scale (SCS) developed by Kristin Neff [ 25 , 26 ]. The Self-Compassion Scale consists of 26 items rated on a five-point Likert scale ranging from "almost never" to "almost always." After reversing the negatively worded items, the scores are summed to yield an overall self-compassion score, with higher scores indicating greater self-compassion [ 26 ]. The reliability of the instrument is excellent, with a Cronbach’s alpha of 0.92 for the total scale, and the six subscales demonstrating Cronbach’s alpha values ranging from 0.75 to 0.81 [ 25 ]. Semi-structured interviews on feasibility To gain a deeper understanding of the program’s effectiveness and relevance, semi-structured interviews were conducted with participants of the intervention. The interviews were carried out by a researcher with clinical psychologist qualifications. The purpose of the interviews was to explore participants’ subjective experiences regarding the usefulness of the group sessions, as well as the extent to which the intervention techniques learned could be integrated into their daily lives. During the interviews, participants were asked questions such as, “Do you think the program addresses problems common among individuals with breast cancer?” and “Do you believe the skills taught in the program would be relevant for others in similar situations to yours?” Additionally, participants evaluated how easy they found the application of the learned techniques in practice (“I thought the learned techniques were easy to use”). The practical utility and applicability of each intervention element were also assessed using a 10-point Visual Analog Scale (VAS), allowing for the quantitative recording of experiences. Statistical processing IBM SPSS 23.0© and JASP software were used for data analyses. First, the internal consistency of the measurement instruments employed in the study was assessed by calculating Cronbach’s alpha coefficients, all of which met acceptable reliability standards. Second, the effectiveness of the intervention was evaluated through comparative analyses, conducted according to the results of normality tests. Effect sizes were initially estimated using Cohen’s d based on mean differences, with values of 0.20, 0.50, and 0.80 interpreted as small, medium, and large effects, respectively [ 27 ]. However, given the relatively small sample size, Hedges’ g was computed to correct for potential bias inherent in Cohen’s d . This correction involves multiplying Cohen’s d by a correction factor based on the degrees of freedom in the sample [ 28 ]. The 95% confidence intervals for Hedges’ g were calculated using its standard error and an appropriate critical t-value to account for small-sample variability. Finally, qualitative data collected through semi-structured interviews regarding the program interventions are presented, focusing on the current sample. Results Pre- and post-intervention results Table 3 presents the descriptive statistics of the applied questionnaires, separated by pre- and post-intervention assessments. The results indicate a statistically significant medium effect size difference in the level of depression, distress, family problems, social control, self-compassion, and stigmatization. In other words, following the group interventions, respondents in the current sample reported lower levels of distress, fewer interpersonal conflicts, reduced depressive symptoms, and decreased stigmatization. Moreover, they perceived the influence of significant others on their illness outcome as less determinant, while their self-compassion increased. Table 3 Descriptive and inferential statistics for pre- and post-intervention assessment. Variable Pre Post t p r* Hedges g [95% CI] Mean SD Mean SD Distress thermometer 4.15 2.76 2.00 2.44 2.569 0.025 0.33 0.667 [0.082. 1.229] Practical problems 1.15 1.21 1.30 1.31 -0.395 0.700 0.38 -0.045 [-0.496.0.408] Family-related issues 0.94 0.49 0.46 0.66 2.144 0.050 0.12 0.557 [0.008. 1.102] Emotional difficulties 2.23 1.78 1.69 1.31 1.460 0.170 0.67 0.332 [-0.138. 0.793 ] Physical symptoms 5.46 2.50 5.53 2.96 -0.143 0.888 0.76 0.000 [-0.452. 0.452] Depression (PHQ4) 3.34 2.80 2.06 1.31 2.310 0.034 0.56 0.532 [0.040. 1.011] Locus of control (MHLC) external control 14.53 7.45 11.53 4.85 1.811 0.095 0.60 0.453 [-0.030. 0.923] internal control 21.46 5.98 19.23 8.32 1.049 0.315 0.77 0.196 [-0.264. 0.649 ] social control 25.46 4.09 23.69 4.13 2.379 0.035 0.78 0.616 [0.043. 1.172] Self-compassion (SCS-SF) 96.07 4.23 98.84 5.09 -2.481 0.029 0.64 0.644 [0.065. 1.203] Stigma (SSCI-8) 15.84 8.47 12.15 3.87 2.153 0.050 0.74 0.695 [0.177. 1.195] Note. PHQ4 : Four-item patient health questionnaire; MHLC : Multidimensional Health Locus of Control Scales. SCS: Self-Compassion Scale. SSCI-8 : Stigma Scale for Chronic Illnesses questionnaire. Effect sizes are reported as Hedges’s g for paired (dependent) samples, corrected for small sample bias. * : The value of r denotes the correlation between pre-test and post-test scores. This value is necessary for the computation of the effect size for a paired-samples (dependent samples) t -test. All t -tests were conducted as two-tailed tests. Patient Satisfaction To assess the perceived effectiveness and relevance of the program, semi-structured interviews were conducted with participants to evaluate patient satisfaction. Based on the responses, the psychotherapeutic group received highly positive feedback from women living with metastatic breast cancer. The overall usefulness of the group was rated with an average score of 9.69 (SD = 0.63) on a 10-point scale, while the therapeutic applicability of the learned techniques during treatment received a mean score of 9.54 (SD = 0.66). A total of 77% of participants reported using the techniques on a weekly basis, and an additional 15% indicated daily use. The thematic relevance and alignment of the program were also rated highly (M = 9.76; SD = 0.44), and all participants agreed that the techniques taught could be beneficial for others in similar situations. The individual components of the intervention were also evaluated positively. Mindfulness exercises were rated as useful by 77% of respondents, self-compassion meditations by 100%, and gratitude and mood journaling practices by 92%. Behavioral activation, assertive communication techniques, and the problem-solving worksheet also received favorable ratings, each with an average score above 8.5. Regarding feasibility, 100% of participants reported that the group was well adapted to their current life circumstances and challenges. All respondents indicated that they would highly recommend the program to others living with cancer, giving it a maximum score (10/10). The results are summarized in Table 4 . Table 4 Descriptive analysis of patient satisfaction outcomes pertaining to the implemented interventions Topic Questions Mean (SD)/ Frequency min, max General Questions How useful did you find the group sessions? 9.69 (0.63) min 8 max 10 To what extent do you feel able to apply the skills learned during the group sessions throughout your treatment? 9.54 (0.66) min 8 max 10 How frequently have you utilized the techniques learned in the group sessions in your daily life? 8% reported using the techniques weekly, 77% used them multiple times per week, and 15% applied them daily. Disease-Specific Fit Do you believe that the program addresses issues commonly experienced by individuals living with breast cancer? 9.76 (0.44) min 9 max 10 Do you think that the skills taught in the program would be relevant to other people in similar situations to yourself? yes 100% Assessment of Interventions I found the learned techniques easy to use. yes 77% no 23% Mindfulness practice 9.30 (0.63) min 8 max 10 Mood diary 9.53 (0.52) min 9 max 10 Self-compassion meditation 9.61 (0.65) min 8 max 10 List of pleasant activities / behavioral activation 8.61 (0.87) min 7 max 10 Gratitude journal 9.46 (0.66) min 8 max 10 Assertive communication 10 min 10 max 10 Problem-solving worksheet 8.53 (0.87) min 7 max 10 Feasibility Did you find the program sufficient? yes 100% Did the program adapt to your current life situation and difficulties? yes 100% Would you recommend participation in the group to individuals living with cancer? 10 min 10 max 10 Discussion This study is the first to examine the applicability of the Four-Session Cognitive-Behavioral Therapy–based Psychological Intervention Program for Oncological Patients (CBT-OP-4) low-intensity, structured psychological intervention in the palliative care of women living with HER2-positive metastatic breast cancer. Our findings suggest that the program is not only feasible within a therapeutic setting, but also associated with positive psychological changes as indicated by both participants’ subjective evaluations and validated psychological assessment tools. Following the intervention, significant reductions were observed in levels of distress, depressive symptoms, family-related conflicts, and stigmatization, while improvements were noted in self-compassion and a reduced perception of the role of social control. These findings are consistent with previous studies demonstrating the effectiveness of cognitive-behavioral interventions in oncology populations [ 10 , 11 , 30 ]. Notably, these changes occurred after only four sessions, highlighting the feasibility of such a brief intervention format within the time constraints and capacity considerations of palliative care. The systematic structure of the program—which integrates elements of psychoeducation, cognitive restructuring, behavioral activation, assertiveness, self-compassion, and coping—enabled participants to process the emotional and social challenges related to their illness in a differentiated manner. According to semi-structured interviews and patient satisfaction feedback, the skills acquired during the sessions were perceived as highly applicable in everyday life, which may support their long-term integration into participants' coping repertoires. These findings underscore the practical relevance of psycho-oncological interventions even among patients with advanced-stage illness [ 15 , 31 ]. Based on our findings, CBT-OP-4 appears to be a potentially effective and feasible tool within the repertoire of psychological support interventions in palliative oncology care. The observed reduction in stigmatization and increase in self-compassion are particularly important for patients whose illness is no longer curable and who often face vulnerability and social isolation [ 5 , 32 ]. Positive changes in patients’ relationship with themselves - especially improvements in self-compassion - may serve as key psychological protective factors, contributing to the maintenance of quality of life in advanced stages of illness [ 12 , 26 ]. It is important to highlight that although the program did not specifically target somatic symptoms or treatment-related side effects, the observed reduction in distress and the structured discussion of problems may have an indirect positive impact on overall well-being and treatment adherence [ 9 , 33 ]. Study limitations Although the findings of this study are promising, several methodological and generalizability limitations must be considered. First, the small sample size considerably limits the statistical power and the validity of inferences. While the applied statistical tests and effect size estimations are indicative, the absence of a randomized controlled trial precludes drawing causal conclusions about the observed changes being solely attributable to the intervention. Second, although the majority of patients enrolled in the study were recruited from a single institution, a few participants were included from other hospitals as well, which reduces the degree of homogeneity and slightly increases the generalizability of the findings. Additionally, the socio-economic status distribution of the participants is not representative of the broader population of HER2-positive metastatic breast cancer patients. Third, psychological effects were assessed using self-report instruments, which may be subject to social desirability bias. Although the structured interviews evaluating the program’s acceptability and feasibility provided valuable qualitative insights, they cannot replace efficacy assessments based on long-term follow-up studies. Finally, although the CBT-OP-4 program is a structured, evidence-based psychological intervention, the intervention was not conducted in isolation but as part of a comprehensive oncological rehabilitation protocol that included peer-to-peer support, nutritional intervention, and medical monitoring, making it impossible to definitively isolate the effects of the individual therapeutic components. Clinical implications Based on the results of the present feasibility study, the CBT-OP-4 represents a clinically relevant, low-intensity psychotherapeutic intervention that, according to our preliminary findings and patient satisfaction assessments, can be effectively integrated into the psychosocial component of palliative care for patients with HER2-positive metastatic breast cancer. The program contributed to reductions in distress, depressive symptoms, and stigmatization, while fostering self-compassion, which multiple studies have identified as a protective factor in psychological adaptation to illness [ 12 , 26 ]. The obtained results further reinforce the justification for integrating psycho-oncological interventions into palliative oncology care, particularly for patient groups who, despite disease progression, can expect longer survival due to targeted therapies [ 3 ]. Alleviating the mental burden of chronic illness is crucial for maintaining patients’ quality of life and sustaining treatment adherence [ 9 , 10 ]. The structured nature, standardized interventions, thematic organization, and brief duration of the CBT-OP-4 protocol facilitate its broader implementation across various clinical settings. The group format allows for cost-effective and efficient delivery in everyday health care environments where psychotherapeutic services are limited. This approach aligns with international efforts to strengthen the multidisciplinary and comprehensive perspective of palliative oncology care [ 31 ]. Clinically, the results confirm the relevance of structured, targeted psychological interventions even among patients with advanced breast cancer, as these interventions can positively impact not only psychological well-being but also, indirectly, treatment adherence and the overall quality of patient care [ 8 , 11 ]. Conclusion The results of the present feasibility study suggest that the CBT-OP-4 program - as a structured, low-intensity, group-based psychological intervention - can be promisingly integrated into the palliative care of women living with HER2-positive metastatic breast cancer. The significant reductions in psychological distress, depressive symptoms, and stigmatization, alongside the increase in self-compassion, indicate psychological changes that may provide potentially clinically relevant support for psychosocial adaptation to cancer diagnosis as well as cancer treatment. The intervention’s favorable acceptability and high practical applicability further reinforce the justification for implementing the program within this particularly vulnerable patient population. Although the small sample size and non-randomized design of the study limit the interpretation of the psychological outcomes, this research provides a valuable foundation for future longitudinal and controlled trials investigating the efficacy and long-term effects of the CBT-OP-4 protocol. To address the ordering anomaly, we emphasize that the psychological analysis, derived from the other endpoints of the study will be the first to be published, as the primary TAT results have not yet been released. The psychological data are scientifically independent of the primary endpoint and, therefore, their analysis does not compromise the integrity of the main trial findings. Our findings also support the necessity of the structured integration of psycho-oncological interventions into palliative care, particularly for patients facing significant psychosocial challenges despite extended survival due to targeted therapies. Declarations Competing Interests The authors declare no competing interests. Funding This research study was in part funded by Roche (Magyarország) Kft. in the form of investigational drugs and financial support being provided to research site. We thank the trial participants and the trial site staff who conducted the studies as well as the leadership of Semmelweis University especially Prof. Dr. Béla Merkely, rector and Prof. Dr. Attila Szabó, vice rector. The publication was prepared in accordance with Good Publication Practice guidelines (ismpp.org/gpp-2022). Author Contribution SzT and VG conceived the study, and developed the theoretical framework, and were responsible for data collection related to the psychological intervention. BMÁ was responsible for designing and developing the study protocol and operationally led the clinical study procedure. MB was responsible for study coordination, clinical study management and clinical data management. PZs was responsible for patient enrollment. SzT and UR analyzed the data. DM supervised the project. All authors discussed the results. Acknowledgement We thank the trial participants and the trial site staff who conducted the studies as well as the leadership of Semmelweis University especially Prof. Dr. Béla Merkely, rector and Prof. Dr. Attila Szabó, vice rector. Data Availability The datasets generated and/or analyzed during the current study are not publicly available due to the sensitive nature of the clinical and psychological data and the risk of participant re-identification, but are available from the corresponding author on reasonable request and with appropriate ethical approval. References GLOBOCAN (2020) France: The International Agency for Research on Cancer. http://globocan.iarc.fr Horr C, Buechler SA (2021) Breast cancer consensus subtypes: A system for subtyping breast cancer tumors based on gene expression. 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Front Health Serv 3:1111677. https://doi.org/10.3389/frhs.2023.1111677 Harish J, Syed A (2025) The role of psychosocial support in enhancing quality of life for cancer patients: Challenges and solutions. J Neonatal Surg 14:384–387. https://doi.org/10.52783/jns.v14.1552 Vizin G, Farkas K (2020) A kognitív viselkedésterápia lehetőségei az onkológiai ellátásban. Magy Onkol 64:62–69 Vizin G (2023) Nem vagy egyedül! Oriold és Társai Kiadó, Budapest Hinz A, Mitchell AJ, Degi CL, Mehnert-Theuerkauf A (2019) Normative values for the distress thermometer and the emotion thermometers derived from a German general population sample. Qual Life Res 28:277–282. https://doi.org/10.1007/s11136-018-2014-1 Kroenke K, Spitzer RL, Williams JB, Löwe B (2009) An ultra-brief screening scale for anxiety and depression: The PHQ-4. Psychosomatics 50:613–621. https://doi.org/10.1176/appi.psy.50.6.613 Molina Y, Choi SW, Cella D, Rao D (2013) The stigma scale for chronic illnesses 8-item version (SSCI-8): Development, validation and use across neurological conditions. Int J Behav Med 20:450–460. https://doi.org/10.1007/s12529-012-9243-4 Szőcs H, Horváth Z, Vizin G (2021) Shame mediates the relationship between stigma and quality of life among patients with coeliac disease: A magyar adaptációs vizsgálat eredményei. Orv Hetil 162:1968–1976. https://doi.org/10.1556/650.2021.32258 Daryaafzoon M, Amini-Tehrani M, Zohrevandi Z, Hamzehlouiyan M, Ghotbi A, Zarrabi-Ajami S, Zamanian H (2020) Translation and factor analysis of the stigma scale for chronic illnesses 8-item version among Iranian women with breast cancer. Asian Pac J Cancer Prev 21(2):449–455. https://doi.org/10.31557/APJCP.2020.21.2.449 Wallston KA, Wallston BS, DeVellis R (1978) Development of the multidimensional health locus of control (MHLC) scales. Health Educ Monogr 6:160–170. https://doi.org/10.1177/109019817800600107 Wallston KA, Stein MJ, Smith CA (1994) Form C of the MHLC scales: A condition-specific measure of locus of control. J Pers Assess 63:534–553. https://doi.org/10.1207/s15327752jpa6303_10 Konkoly Thege B, Rafael B, Rohánszky M (2014) Psychometric properties of the multidimensional health locus of control scale form C in a non-Western culture. PLoS One 9:e107108. https://doi.org/10.1371/journal.pone.0107108 Neff KD, Germer CK (2013) A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol 69:28–44. https://doi.org/10.1002/jclp.21923 Tóth-Király I, Bőthe B, Orosz G (2017) Exploratory structural equation modeling analysis of the Self-Compassion Scale. Mindfulness 8:881–892. https://doi.org/10.1007/s12671-016-0662-1 Cohen J (1988) Statistical power analysis for the behavioral sciences , 2nd edn. Lawrence Erlbaum Hedges LV, Olkin I (2014) Statistical methods for meta-analysis . Elsevier Science Moorey S (2010) Cognitive therapy. In: Holland J, Breitbart W, Jacobsen P et al (eds) Psycho-oncology , 2nd edn. Oxford University Press, pp 402–407 Uitterhoeve RJ, Vernooy M, Litjens M et al (2004) Psychosocial interventions for patients with advanced cancer: A systematic review of the literature. Br J Cancer 91:1050–1062. https://doi.org/10.1038/sj.bjc.6602051 Else-Quest NM, LoConte NK, Schiller JH, Hyde JS (2009) Perceived stigma, self-blame, and adjustment among lung, breast and prostate cancer patients. Psychol Health 24:949–964 Pinquart M, Duberstein PR (2010) Associations of social networks with cancer mortality: A meta-analysis. Crit Rev Oncol Hematol 75:122–137. https://doi.org/10.1016/j.critrevonc.2009.06.003 Deshields TL, Heiland MF, Kracen AC, Dua P (2016) Resilience in adults with cancer: Development of a conceptual model. Psychooncology 25:11–18 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 24 Mar, 2026 Reviews received at journal 24 Mar, 2026 Reviews received at journal 09 Mar, 2026 Reviewers agreed at journal 04 Mar, 2026 Reviewers agreed at journal 02 Mar, 2026 Reviewers invited by journal 17 Feb, 2026 Editor assigned by journal 16 Feb, 2026 Submission checks completed at journal 25 Jan, 2026 First submitted to journal 13 Jan, 2026 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. 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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-8595208","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":593540696,"identity":"fa2eee57-7dc2-440a-9f55-c04c2fe978d2","order_by":0,"name":"Tamás Szekeres","email":"","orcid":"","institution":"National Institute of Oncology","correspondingAuthor":false,"prefix":"","firstName":"Tamás","middleName":"","lastName":"Szekeres","suffix":""},{"id":593540699,"identity":"e0658fe9-b5cc-40d0-a624-e905f77b5e17","order_by":1,"name":"Máté Ádám Balázs","email":"","orcid":"","institution":"Semmelweis University","correspondingAuthor":false,"prefix":"","firstName":"Máté","middleName":"Ádám","lastName":"Balázs","suffix":""},{"id":593540701,"identity":"f3c867f1-fac5-43a1-ae4e-484ca71608a4","order_by":2,"name":"Bálint Madarász","email":"","orcid":"","institution":"Semmelweis University","correspondingAuthor":false,"prefix":"","firstName":"Bálint","middleName":"","lastName":"Madarász","suffix":""},{"id":593540703,"identity":"204b9c6c-1221-485a-b275-1074a0ac6010","order_by":3,"name":"Zsuzsa Póti","email":"","orcid":"","institution":"Uzsoki Street Hospital","correspondingAuthor":false,"prefix":"","firstName":"Zsuzsa","middleName":"","lastName":"Póti","suffix":""},{"id":593540705,"identity":"2d9833e9-2011-499f-852a-ca05ca140a68","order_by":4,"name":"Róbert Urbán","email":"","orcid":"","institution":"Eötvös Loránd University","correspondingAuthor":false,"prefix":"","firstName":"Róbert","middleName":"","lastName":"Urbán","suffix":""},{"id":593540706,"identity":"f0d503c8-e895-412e-b148-fe092b6497a2","order_by":5,"name":"Magdolna Dank","email":"","orcid":"","institution":"National Institute of Oncology","correspondingAuthor":false,"prefix":"","firstName":"Magdolna","middleName":"","lastName":"Dank","suffix":""},{"id":593540707,"identity":"d64771e3-902f-4b75-b9b8-42bb88c42cb8","order_by":6,"name":"Gabriella Vizin","email":"data:image/png;base64,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","orcid":"","institution":"Eötvös Loránd University","correspondingAuthor":true,"prefix":"","firstName":"Gabriella","middleName":"","lastName":"Vizin","suffix":""}],"badges":[],"createdAt":"2026-01-13 19:23:05","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8595208/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8595208/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":103168011,"identity":"0381a64a-2e50-4c0a-b7c1-f167076a4162","added_by":"auto","created_at":"2026-02-22 12:57:00","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":103496,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eStudy Design\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8595208/v1/0c825454f97d960078d29764.jpeg"},{"id":103505276,"identity":"96eda32e-c7a7-4c7b-9ddb-fca6aed08598","added_by":"auto","created_at":"2026-02-26 13:29:20","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1303700,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8595208/v1/2c78339f-0d04-4a8c-97af-a637498fd833.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Feasibility Study of the Four-Session Cognitive-Behavioral Therapy–based Psychological Intervention Program for Women with HER2-Positive Metastatic Breast Cancer","fulltext":[{"header":"Introduction","content":"\u003cp\u003eBreast cancer remains the most commonly diagnosed malignancy among women worldwide [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The classification of breast cancer subtypes - such as luminal A, luminal B, human epidermal growth factor receptor 2 (HER2) -positive, and basal-like\u0026mdash;is essential for developing personalized treatment strategies, as each subtype is associated with distinct prognoses and therapeutic responses [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The HER2-positive subtype accounts for approximately 15\u0026ndash;20% of cases and is characterized by aggressive clinical behavior, rapid progression, and a higher recurrence rate [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Although HER2-targeted therapies (e.g., trastuzumab, pertuzumab) have significantly improved patient outcomes, in metastatic settings the disease remains a chronic, incurable condition that requires complex treatment and a multidisciplinary care approach [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite the survival benefits achieved with anti-HER2 targeted therapies in patients with metastatic disease, the psychosocial burden during the chronic, non-curative phase remains substantial [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. These patients typically undergo continuous maintenance therapy, resulting in ongoing exposure to treatment-related side effects such as cardiotoxicity, altered immune response, gastrointestinal disturbances, and dermatological or hair-related issues [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Moreover, research has shown that a diagnosis of metastatic disease is frequently associated with elevated levels of psychological distress, depressive and anxiety symptoms, and perceived stigma [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. These psychological burdens negatively impact quality of life, may compromise treatment adherence, and can ultimately reduce overall survival [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn palliative care, there is an increasingly recognized need for integrated psychological interventions, a demand supported by the growing body of meta-analytic evidence demonstrating their positive effects on psychological outcomes [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Evidence-based psychotherapeutic approaches such as cognitive-behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), self-compassion training, and positive psychology interventions have shown effectiveness in reducing psychological distress, depression, anxiety, and perceived stigma. These approaches also contribute to improved quality of life, enhanced coping skills, and, in some cases, better adherence and survival outcomes [\u003cspan additionalcitationids=\"CR11 CR12 CR13\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAlthough comprehensive CBT-based programs have been developed to improve quality of life and treatment adherence among oncology patients [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], no such integrated program has been specifically tailored to the psychological needs of patients with HER2-positive metastatic breast cancer receiving palliative care (e.g., trastuzumab, pertuzumab). To date, there has been no comprehensive intervention that incorporates evidence-based psychotherapeutic tools adapted to the complex psychosocial context of this patient population.\u003c/p\u003e \u003cp\u003eThe aim of the present study is to provide a brief overview of a comprehensive, low-intensity, group-based cognitive-behavioral therapy intervention (Four-Session Cognitive-Behavioral Therapy\u0026ndash;based Psychological Intervention Program for Oncological Patients; CBT-OP-4), specifically developed for women with HER2-positive metastatic breast cancer receiving palliative care. In addition, the study seeks to assess the feasibility and report preliminary outcomes concerning the intervention\u0026rsquo;s effectiveness.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003eSample and procedure\u003c/h2\u003e\n \u003cp\u003eThe prospective feasibility study was conducted within an investigator initiated academic study (IIS) - titled \u0026ldquo; Value-based health economic comparative study of subcutaneous and intravenous pertuzumab-trastuzumab for HER2 positive metastatic breast cancer based on patient reported outcomes.\u0026rdquo; - in 2023\u0026ndash;2025. The overall study was to perform value-based health economic comparison of subcutaneous and intravenous pertuzumab-trastuzumab for HER2 positive metastatic breast cancer based on patient reported outcomes. Furthermore, a comprehensive onco-rehabilitation program was involved in this academic study, such as a peer-to-peer support program conducted by patient organization, nutritional therapy intervention, and a brief, comprehensive CBT-based psychological support program (Four-Session Cognitive-Behavioral Therapy\u0026ndash;based Psychological Intervention Program for Oncological Patients, CBT-OP-4). The full study protocol is illustrated in Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n \u003cp\u003eParticipants were recruited from multiple oncology centers in Hungary. A total of 23 patients participated in the study, including 16 from the Oncology Profile of the Department of Internal Medicine and Oncology at Semmelweis University, 5 from Uzsoki Street Hospital, 1 from the University of Debrecen, and 1 from the South-Pest Central Hospital.\u003c/p\u003e\n \u003cp\u003eThe intervention group (n\u0026thinsp;=\u0026thinsp;13) consisted of participants from the University of Debrecen (n\u0026thinsp;=\u0026thinsp;1), Uzsoki Street Hospital (n\u0026thinsp;=\u0026thinsp;2), and Semmelweis University (n\u0026thinsp;=\u0026thinsp;10).\u003c/p\u003e\n \u003cp\u003eThe study sample consisted of patients enrolled in the IIS; sampling was voluntary and based on strict inclusion and exclusion criteria.\u003c/p\u003e\n \u003cp\u003eThe inclusion and exclusion criteria of the overall study also applied to the CBT-OP-4 psychological support program. The following inclusion criteria were required: written informed consent from the patient; the patient had to finish induction therapy with pertuzumab and trastuzumab with chemotherapy for breast cancer; age of at least 18 years at the time of enrollment; confirmed HER2-positive, locally advanced, unresectable or metastatic breast cancer, confirmed by imaging and histopathological examination, irrespective of hormone receptor status; Ability to comply with the study protocol; Eastern Cooperative Oncology Group (ECOG) performance status of 0\u0026ndash;1; good patient adherence; baseline left ventricular ejection fraction (LVEF) of at least 50% measured by echocardiography; no contraindications of pertuzumab and trastuzumab treatment; and an expected survival exceeding six months.\u003c/p\u003e\n \u003cp\u003ePatients were excluded from the study if they met any of the following exclusion criteria: use of a port catheter for intravenous drug administration; age above 75 years; early-stage breast cancer without confirmed local or distant metastases; progression during pertuzumab and trastuzumab therapy; pregnancy and/or breastfeeding; severe cardiovascular comorbidities, especially New York Heart Association (NYHA) functional class II\u0026ndash;IV; pregnancy or lactation; presence of severe psychiatric disorders; current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders); inadequate bone marrow function; impaired liver function; and impaired renal function (serum creatinine\u0026thinsp;\u0026gt;\u0026thinsp;1.5 \u0026times; upper limit of normal). Any medical condition or laboratory abnormality that, in the investigator\u0026rsquo;s judgment, would jeopardize the patient\u0026rsquo;s safe participation in the study also led to exclusion. Additionally, patients with active liver disease (e.g., hepatitis B or C infection, autoimmune hepatitis, sclerosing cholangitis), concurrent severe uncontrolled infections, known HIV infection, or known hypersensitivity to the investigational drugs, excipients, or murine-derived proteins; were excluded. Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e presents the descriptive statistics of the study sample.\u003c/p\u003e\n \u003cp\u003eThe study has been registered in the European Medicines Agency (EMA) clinical trials database under the EudraCT number 2023-000156-38. The study protocol number is 20230123SE. Hungarian Health Authority approved and granted.\u003c/p\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eDemographics and disease-related information\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eVariable\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eFrequency/mean (SD)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e63 (8.05)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eRelationship status\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eWidowed\u003c/p\u003e\n \u003cp\u003eDivorced\u003c/p\u003e\n \u003cp\u003eMarried\u003c/p\u003e\n \u003cp\u003eIn a relationship\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e3 (23%)\u003c/p\u003e\n \u003cp\u003e2 (15%)\u003c/p\u003e\n \u003cp\u003e6 (47%)\u003c/p\u003e\n \u003cp\u003e2 (23%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlace of residence\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eCapital city\u003c/p\u003e\n \u003cp\u003eVillage\u003c/p\u003e\n \u003cp\u003eTown / City\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e5 (38%)\u003c/p\u003e\n \u003cp\u003e2 (15%)\u003c/p\u003e\n \u003cp\u003e6 (47%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eEducational attainment\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eElementary school\u003c/p\u003e\n \u003cp\u003eVocational school / Technical school\u003c/p\u003e\n \u003cp\u003eHigh school\u003c/p\u003e\n \u003cp\u003eBachelor\u0026rsquo;s degree (BSc)\u003c/p\u003e\n \u003cp\u003eMaster\u0026rsquo;s degree (MSc)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e1 (8%)\u003c/p\u003e\n \u003cp\u003e1 (8%)\u003c/p\u003e\n \u003cp\u003e3 (23%)\u003c/p\u003e\n \u003cp\u003e7 (53%)\u003c/p\u003e\n \u003cp\u003e1 (8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eNumber of years since diagnosis\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10,61 (6,87)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eElapsed time (in years) since the diagnosis of metastatic disease\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7,38 (5,59)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eHormone receptor status\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eEstrogen receptor (ER) positive\u003c/p\u003e\n \u003cp\u003eHormone receptor negative\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e4 (31%)\u003c/p\u003e\n \u003cp\u003e9 (69%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eSite(s) of metastasis\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eSkin\u003c/p\u003e\n \u003cp\u003eBone\u003c/p\u003e\n \u003cp\u003eBone and lymph nodes\u003c/p\u003e\n \u003cp\u003eBone and liver\u003c/p\u003e\n \u003cp\u003eLiver and lung\u003c/p\u003e\n \u003cp\u003eLymph nodes and brain\u003c/p\u003e\n \u003cp\u003eLymph nodes\u003c/p\u003e\n \u003cp\u003eLung\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e1 (8%)\u003c/p\u003e\n \u003cp\u003e3 (23%)\u003c/p\u003e\n \u003cp\u003e2 (15%)\u003c/p\u003e\n \u003cp\u003e2 (15%)\u003c/p\u003e\n \u003cp\u003e1 (8%)\u003c/p\u003e\n \u003cp\u003e1 (8%)\u003c/p\u003e\n \u003cp\u003e2 (15%)\u003c/p\u003e\n \u003cp\u003e1 (8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cbr\u003e\u003cstrong\u003eEthics\u003c/strong\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003eThe study was conducted in accordance with the latest version of the Declaration of Helsinki and complied with applicable Good Clinical Practice (GCP) guidelines. Ethical approval for the research was granted by the Medical Research Council \u0026ndash; Ethics Committee for Clinical Pharmacology (MRC ECCP - ETT KFEB), under the reference number BM/6420-0/2023-EKL.\u003c/p\u003e\n\u003ch3\u003eInterventions (Four-Session Cognitive-Behavioral Therapy\u0026ndash;based Psychological Intervention Program for Oncological Patients, CBT-OP-4)\u003c/h3\u003e\n\u003cp\u003eParticipants took part in a four-week, low-intensity, group-based cognitive-behavioral therapy intervention consisting of four sessions. Each session lasted 120 minutes and was facilitated by a cognitive-behavioral therapy (CBT) trained therapist alongside a clinical psychologist with specialized training in CBT.\u003c/p\u003e\n\u003cp\u003eThe intervention was based on the CBT \u0026ndash; based psychological intervention program for Oncological Patients (CBT-OP), developed by Vizin [\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e]. This program was originally designed to reduce psychological symptoms related to cancer and its treatments, and to enhance treatment adherence, specifically for women with Grade I\u0026ndash;III breast cancer. The original program consists of ten group sessions, with core components including cognitive restructuring, behavioral activation, problem-solving, education and psychoeducation, as well as mindfulness and self-compassion meditation. We adapted this program for use with women receiving palliative care.\u003c/p\u003e\n\u003cp\u003eAt the beginning of the program, participants received a workbook containing diaries, psychoeducational materials, and related worksheets. Each session commenced with a review of the home practice diaries. Every session included psychoeducational components, psychological intervention elements, home practice assignments, and group discussions related to these activities. Participants were sent reminder emails on the day following each session, which included materials for the week\u0026rsquo;s exercises. Sessions concluded with brief mindfulness and self-compassion meditation practices. The CBT-OP-4 program was structured as follows (Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.):\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eStructure of the Four-Session Cognitive-behavioral Therapy - based psychological intervention program for Oncological Patients (CBT-OP-4)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSession\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eTopic\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eIntervention\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003ePsychological assessment\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAssessed domains: depression, anxiety, distress, problem checklist, levels of stigmatization and shame, and self-compassion.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDistress Thermometer, PHQ-4, SSCI-8, PCS, MHLC-C, SCS-SF\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eFirst session\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePsychoeducation, emotion validation, cognitive model\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ecognitive conceptualization, Three-column reflective journal\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eSecond session\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDepression and anxiety education, behavioral activation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eList of pleasant activities, mood diary\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eThird session\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAssertiveness, resilience\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAssertiveness training, resilience exercise [\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e], gratitude journal\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eFourth session\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCrisis, coping, problem solving\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePsychoeducation on the cognitive model of coping with cancer, problem-solving worksheet\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"3\"\u003e\n \u003cp\u003eMindfulness and self-compassion practice at the end of each session\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003ePsychological assessment\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAssessed domains: depression, anxiety, distress and problem checklist, levels of stigmatization and shame, self-compassion\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDistress Thermometer, PHQ-4, SSCI-8, PCS, MHLC-C, SCS-SF\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003eFeasibility\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eEvaluation of the program\u0026rsquo;s effectiveness and relevance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSemi-structured interview\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\"\u003e\u003cem\u003eNote. PHQ4\u003c/em\u003e: Four-item patient health questionnaire; \u003cem\u003eMHLC\u003c/em\u003e: Multidimensional Health Locus of Control Scales. SCS: Self-Compassion Scale. \u003cem\u003eSSCI-8\u003c/em\u003e: Stigma Scale for Chronic Illnesses questionnaire.\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eParticipants\u0026rsquo; psychological status was assessed at two time points: prior to the intervention (baseline) and post-intervention. Validated self-administered questionnaires were employed to measure the psychological effects.\u003c/p\u003e\n\u003ch3\u003eMeasures\u003c/h3\u003e\n\u003cp\u003e\u003cstrong\u003eDemographic and disease-related data\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData collection on demographic and disease-specific variables included age, relationship status, educational attainment, type of residence, date of initial breast cancer diagnosis, date of metastatic breast cancer diagnosis, hormone receptor status, and sites of metastasis.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDistress Thermometer\u003c/em\u003e [\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e]: To measure psychological distress, the Distress Thermometer was employed, which is a single-item, 11-point visual analog scale ranging from 0 to 10. A score of 0 indicates no distress, while 10 represents the highest level of distress. Participants rated the level of distress they experienced over the past week, including the current day, by selecting a number on the scale. Complementing the scale is a 40-item problem checklist designed to identify sources of distress across six thematic categories: practical, family, emotional, spiritual/religious, physical, and other problems. Respondents indicated \u0026quot;yes\u0026quot; or \u0026quot;no\u0026quot; for each item depending on whether they experienced the specific problem during the past week.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFour-item patient health questionnaire for anxiety and depression (PHQ-4) [\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe PHQ-4 is an ultrabrief, four-item self-administered psychological screening tool designed to rapidly detect symptoms of depression and anxiety. The questionnaire combines the Generalized Anxiety Disorder-2 (GAD-2) and the Patient Health Questionnaire-2 (PHQ-2), each comprising two items that measure symptoms of anxiety and depression, respectively [\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e]. Responses are given on a four-point Likert scale (0\u0026ndash;3), reflecting symptom frequency over the past two weeks. The total score ranges from 0 to 12 and indicates the overall level of psychological distress, while subscale scores for anxiety and depression can be evaluated separately. The PHQ-4 demonstrates excellent psychometric properties and has been validated across various clinical and non-clinical populations, including oncology patients. The scale exhibits high sensitivity and specificity, making it particularly suitable for low-intensity settings and somatically burdened, older populations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStigma Scale for Chronic Illnesses questionnaire (SSCI-8) [\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo assess stigmatization, the 8-item Stigma Scale for Chronic Illnesses (SSCI-8); was utilized. The questionnaire consists of eight items, making it suitable for use in clinical settings [\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e]. Participants rate statements such as \u0026ldquo;I felt embarrassed about my illness\u0026rdquo; and \u0026ldquo;Some people treated me as if it was my fault that I have this illness\u0026rdquo; on a 4-point Likert scale (1\u0026thinsp;=\u0026thinsp;never, 4\u0026thinsp;=\u0026thinsp;always). Scores range from 8 to 40, with higher scores indicating greater perceived stigmatization [\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e]. The instrument has demonstrated validity and reliability, with a Cronbach\u0026rsquo;s alpha of 0.89 [\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e]. Among samples of women with breast cancer, it has shown good test\u0026ndash;retest reliability (r\u0026thinsp;=\u0026thinsp;0.78) and internal consistency (Cronbach\u0026rsquo;s alpha\u0026thinsp;=\u0026thinsp;0.89) [\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eForm C of the Multidimensional Health Locus of Control Scales questionnaire (MHLC-C)\u003c/em\u003e [\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e]: To assess health-related locus of control, the Hungarian version of the Multidimensional Health Locus of Control (MHLC) Form C questionnaire was utilized [\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e]. This instrument is specifically designed to evaluate the health locus of control among individuals living with chronic illnesses. The questionnaire comprises three subscales: internal control, external control (chance or luck), and social control. It contains no reverse-scored items. Individuals perceiving a high level of internal control believe they actively influence their own health. When the \u0026ldquo;chance\u0026rdquo; factor predominates, the course of the illness appears more unpredictable to the respondent. External control is characterized by a belief that the outcome of the illness is primarily determined by physicians or other significant individuals whom the person trusts.\u003c/p\u003e\n\u003cp\u003eSelf-compassion was assessed using the Hungarian adaptation of the \u003cem\u003eSelf-Compassion Scale (SCS)\u003c/em\u003e developed by Kristin Neff [\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e]. The Self-Compassion Scale consists of 26 items rated on a five-point Likert scale ranging from \u0026quot;almost never\u0026quot; to \u0026quot;almost always.\u0026quot; After reversing the negatively worded items, the scores are summed to yield an overall self-compassion score, with higher scores indicating greater self-compassion [\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e]. The reliability of the instrument is excellent, with a Cronbach\u0026rsquo;s alpha of 0.92 for the total scale, and the six subscales demonstrating Cronbach\u0026rsquo;s alpha values ranging from 0.75 to 0.81 [\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSemi-structured interviews on feasibility\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo gain a deeper understanding of the program\u0026rsquo;s effectiveness and relevance, semi-structured interviews were conducted with participants of the intervention. The interviews were carried out by a researcher with clinical psychologist qualifications. The purpose of the interviews was to explore participants\u0026rsquo; subjective experiences regarding the usefulness of the group sessions, as well as the extent to which the intervention techniques learned could be integrated into their daily lives. During the interviews, participants were asked questions such as, \u0026ldquo;Do you think the program addresses problems common among individuals with breast cancer?\u0026rdquo; and \u0026ldquo;Do you believe the skills taught in the program would be relevant for others in similar situations to yours?\u0026rdquo; Additionally, participants evaluated how easy they found the application of the learned techniques in practice (\u0026ldquo;I thought the learned techniques were easy to use\u0026rdquo;). The practical utility and applicability of each intervention element were also assessed using a 10-point Visual Analog Scale (VAS), allowing for the quantitative recording of experiences.\u003c/p\u003e\n\u003ch3\u003eStatistical processing\u003c/h3\u003e\n\u003cp\u003eIBM SPSS 23.0\u0026copy; and JASP software were used for data analyses. First, the internal consistency of the measurement instruments employed in the study was assessed by calculating Cronbach\u0026rsquo;s alpha coefficients, all of which met acceptable reliability standards. Second, the effectiveness of the intervention was evaluated through comparative analyses, conducted according to the results of normality tests. Effect sizes were initially estimated using Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e based on mean differences, with values of 0.20, 0.50, and 0.80 interpreted as small, medium, and large effects, respectively [\u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e]. However, given the relatively small sample size, Hedges\u0026rsquo; \u003cem\u003eg\u003c/em\u003e was computed to correct for potential bias inherent in Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e. This correction involves multiplying Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e by a correction factor based on the degrees of freedom in the sample [\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e]. The 95% confidence intervals for Hedges\u0026rsquo; g were calculated using its standard error and an appropriate critical t-value to account for small-sample variability. Finally, qualitative data collected through semi-structured interviews regarding the program interventions are presented, focusing on the current sample.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003ePre- and post-intervention results\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e presents the descriptive statistics of the applied questionnaires, separated by pre- and post-intervention assessments. The results indicate a statistically significant medium effect size difference in the level of depression, distress, family problems, social control, self-compassion, and stigmatization. In other words, following the group interventions, respondents in the current sample reported lower levels of distress, fewer interpersonal conflicts, reduced depressive symptoms, and decreased stigmatization. Moreover, they perceived the influence of significant others on their illness outcome as less determinant, while their self-compassion increased.\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\u003eDescriptive and inferential statistics for pre- and post-intervention assessment.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"9\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" 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=\"char\" char=\".\" 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 \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003ePre\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003ePost\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003et\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003er*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eHedges g\u003c/p\u003e \u003cp\u003e[95% CI]\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSD\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMean\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eSD\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\u003eDistress thermometer\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.76\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e2.569\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.025\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.667\u003c/p\u003e \u003cp\u003e[0.082. 1.229]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePractical problems\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e-0.395\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.700\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e-0.045\u003c/p\u003e \u003cp\u003e[-0.496.0.408]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFamily-related issues\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.94\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e2.144\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.050\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.557\u003c/p\u003e \u003cp\u003e[0.008. 1.102]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEmotional difficulties\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1.460\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.170\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.332\u003c/p\u003e \u003cp\u003e[-0.138. 0.793 ]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePhysical symptoms\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e-0.143\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.888\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.76\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.000\u003c/p\u003e \u003cp\u003e[-0.452. 0.452]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDepression (PHQ4)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e2.310\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.034\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.532\u003c/p\u003e \u003cp\u003e[0.040. 1.011]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eLocus of control (MHLC)\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003eexternal control\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7.45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4.85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.811\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.095\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.453\u003c/p\u003e \u003cp\u003e[-0.030. 0.923]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003einternal control\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e21.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e19.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e8.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1.049\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.315\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.77\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.196\u003c/p\u003e \u003cp\u003e[-0.264. 0.649 ]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003esocial control\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e25.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e23.69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e4.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e2.379\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.035\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.616\u003c/p\u003e \u003cp\u003e[0.043. 1.172]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSelf-compassion (SCS-SF)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e96.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e98.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e5.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e-2.481\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.029\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.644\u003c/p\u003e \u003cp\u003e[0.065. 1.203]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eStigma (SSCI-8)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e15.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e12.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e3.87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e2.153\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.050\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.695\u003c/p\u003e \u003cp\u003e[0.177. 1.195]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"9\"\u003e\u003cem\u003eNote. PHQ4\u003c/em\u003e: Four-item patient health questionnaire; \u003cem\u003eMHLC\u003c/em\u003e: Multidimensional Health Locus of Control Scales. SCS: Self-Compassion Scale. \u003cem\u003eSSCI-8\u003c/em\u003e: Stigma Scale for Chronic Illnesses questionnaire. Effect sizes are reported as Hedges\u0026rsquo;s g for paired (dependent) samples, corrected for small sample bias. \u003cem\u003e*\u003c/em\u003e: The value of \u003cem\u003er\u003c/em\u003e denotes the correlation between pre-test and post-test scores. This value is necessary for the computation of the effect size for a paired-samples (dependent samples) \u003cem\u003et\u003c/em\u003e-test. All \u003cem\u003et\u003c/em\u003e-tests were conducted as two-tailed tests.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePatient Satisfaction\u003c/h3\u003e\n\u003cp\u003eTo assess the perceived effectiveness and relevance of the program, semi-structured interviews were conducted with participants to evaluate patient satisfaction. Based on the responses, the psychotherapeutic group received highly positive feedback from women living with metastatic breast cancer. The overall usefulness of the group was rated with an average score of 9.69 (SD\u0026thinsp;=\u0026thinsp;0.63) on a 10-point scale, while the therapeutic applicability of the learned techniques during treatment received a mean score of 9.54 (SD\u0026thinsp;=\u0026thinsp;0.66). A total of 77% of participants reported using the techniques on a weekly basis, and an additional 15% indicated daily use. The thematic relevance and alignment of the program were also rated highly (M\u0026thinsp;=\u0026thinsp;9.76; SD\u0026thinsp;=\u0026thinsp;0.44), and all participants agreed that the techniques taught could be beneficial for others in similar situations.\u003c/p\u003e \u003cp\u003eThe individual components of the intervention were also evaluated positively. Mindfulness exercises were rated as useful by 77% of respondents, self-compassion meditations by 100%, and gratitude and mood journaling practices by 92%. Behavioral activation, assertive communication techniques, and the problem-solving worksheet also received favorable ratings, each with an average score above 8.5.\u003c/p\u003e \u003cp\u003eRegarding feasibility, 100% of participants reported that the group was well adapted to their current life circumstances and challenges. All respondents indicated that they would highly recommend the program to others living with cancer, giving it a maximum score (10/10). The results are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDescriptive analysis of patient satisfaction outcomes pertaining to the implemented interventions\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\u003eTopic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eQuestions\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMean (SD)/ Frequency\u003c/p\u003e \u003cp\u003emin, max\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eGeneral Questions\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHow useful did you find the group sessions?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.69 (0.63)\u003c/p\u003e \u003cp\u003emin 8\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTo what extent do you feel able to apply the skills learned during the group sessions throughout your treatment?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.54 (0.66)\u003c/p\u003e \u003cp\u003emin 8\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHow frequently have you utilized the techniques learned in the group sessions in your daily life?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8% reported using the techniques weekly,\u003c/p\u003e \u003cp\u003e77% used them multiple times per week,\u003c/p\u003e \u003cp\u003eand 15% applied them daily.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eDisease-Specific Fit\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDo you believe that the program addresses issues commonly experienced by individuals living with breast cancer?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.76 (0.44)\u003c/p\u003e \u003cp\u003emin 9\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDo you think that the skills taught in the program would be relevant to other people in similar situations to yourself?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eyes 100%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"7\" rowspan=\"8\"\u003e \u003cp\u003e\u003cb\u003eAssessment of Interventions\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eI found the learned techniques easy to use.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eyes 77%\u003c/p\u003e \u003cp\u003eno 23%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMindfulness practice\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.30 (0.63)\u003c/p\u003e \u003cp\u003emin 8\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMood diary\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.53 (0.52)\u003c/p\u003e \u003cp\u003emin 9\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSelf-compassion meditation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.61 (0.65)\u003c/p\u003e \u003cp\u003emin 8\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eList of pleasant activities / behavioral activation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.61 (0.87)\u003c/p\u003e \u003cp\u003emin 7\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGratitude journal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.46 (0.66)\u003c/p\u003e \u003cp\u003emin 8\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAssertive communication\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003cp\u003emin 10\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eProblem-solving worksheet\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.53 (0.87)\u003c/p\u003e \u003cp\u003emin 7\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eFeasibility\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDid you find the program sufficient?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eyes 100%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDid the program adapt to your current life situation and difficulties?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eyes 100%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWould you recommend participation in the group to individuals living with cancer?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003cp\u003emin 10\u003c/p\u003e \u003cp\u003emax 10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study is the first to examine the applicability of the Four-Session Cognitive-Behavioral Therapy\u0026ndash;based Psychological Intervention Program for Oncological Patients (CBT-OP-4) low-intensity, structured psychological intervention in the palliative care of women living with HER2-positive metastatic breast cancer. Our findings suggest that the program is not only feasible within a therapeutic setting, but also associated with positive psychological changes as indicated by both participants\u0026rsquo; subjective evaluations and validated psychological assessment tools.\u003c/p\u003e \u003cp\u003eFollowing the intervention, significant reductions were observed in levels of distress, depressive symptoms, family-related conflicts, and stigmatization, while improvements were noted in self-compassion and a reduced perception of the role of social control. These findings are consistent with previous studies demonstrating the effectiveness of cognitive-behavioral interventions in oncology populations [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Notably, these changes occurred after only four sessions, highlighting the feasibility of such a brief intervention format within the time constraints and capacity considerations of palliative care.\u003c/p\u003e \u003cp\u003eThe systematic structure of the program\u0026mdash;which integrates elements of psychoeducation, cognitive restructuring, behavioral activation, assertiveness, self-compassion, and coping\u0026mdash;enabled participants to process the emotional and social challenges related to their illness in a differentiated manner. According to semi-structured interviews and patient satisfaction feedback, the skills acquired during the sessions were perceived as highly applicable in everyday life, which may support their long-term integration into participants' coping repertoires. These findings underscore the practical relevance of psycho-oncological interventions even among patients with advanced-stage illness [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eBased on our findings, CBT-OP-4 appears to be a potentially effective and feasible tool within the repertoire of psychological support interventions in palliative oncology care. The observed reduction in stigmatization and increase in self-compassion are particularly important for patients whose illness is no longer curable and who often face vulnerability and social isolation [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. Positive changes in patients\u0026rsquo; relationship with themselves - especially improvements in self-compassion - may serve as key psychological protective factors, contributing to the maintenance of quality of life in advanced stages of illness [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIt is important to highlight that although the program did not specifically target somatic symptoms or treatment-related side effects, the observed reduction in distress and the structured discussion of problems may have an indirect positive impact on overall well-being and treatment adherence [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e].\u003c/p\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eStudy limitations\u003c/h2\u003e \u003cp\u003eAlthough the findings of this study are promising, several methodological and generalizability limitations must be considered. First, the small sample size considerably limits the statistical power and the validity of inferences. While the applied statistical tests and effect size estimations are indicative, the absence of a randomized controlled trial precludes drawing causal conclusions about the observed changes being solely attributable to the intervention.\u003c/p\u003e \u003cp\u003eSecond, although the majority of patients enrolled in the study were recruited from a single institution, a few participants were included from other hospitals as well, which reduces the degree of homogeneity and slightly increases the generalizability of the findings.\u003c/p\u003e \u003cp\u003eAdditionally, the socio-economic status distribution of the participants is not representative of the broader population of HER2-positive metastatic breast cancer patients.\u003c/p\u003e \u003cp\u003eThird, psychological effects were assessed using self-report instruments, which may be subject to social desirability bias. Although the structured interviews evaluating the program\u0026rsquo;s acceptability and feasibility provided valuable qualitative insights, they cannot replace efficacy assessments based on long-term follow-up studies.\u003c/p\u003e \u003cp\u003eFinally, although the CBT-OP-4 program is a structured, evidence-based psychological intervention, the intervention was not conducted in isolation but as part of a comprehensive oncological rehabilitation protocol that included peer-to-peer support, nutritional intervention, and medical monitoring, making it impossible to definitively isolate the effects of the individual therapeutic components.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eClinical implications\u003c/h2\u003e \u003cp\u003eBased on the results of the present feasibility study, the CBT-OP-4 represents a clinically relevant, low-intensity psychotherapeutic intervention that, according to our preliminary findings and patient satisfaction assessments, can be effectively integrated into the psychosocial component of palliative care for patients with HER2-positive metastatic breast cancer. The program contributed to reductions in distress, depressive symptoms, and stigmatization, while fostering self-compassion, which multiple studies have identified as a protective factor in psychological adaptation to illness [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe obtained results further reinforce the justification for integrating psycho-oncological interventions into palliative oncology care, particularly for patient groups who, despite disease progression, can expect longer survival due to targeted therapies [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Alleviating the mental burden of chronic illness is crucial for maintaining patients\u0026rsquo; quality of life and sustaining treatment adherence [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe structured nature, standardized interventions, thematic organization, and brief duration of the CBT-OP-4 protocol facilitate its broader implementation across various clinical settings. The group format allows for cost-effective and efficient delivery in everyday health care environments where psychotherapeutic services are limited. This approach aligns with international efforts to strengthen the multidisciplinary and comprehensive perspective of palliative oncology care [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eClinically, the results confirm the relevance of structured, targeted psychological interventions even among patients with advanced breast cancer, as these interventions can positively impact not only psychological well-being but also, indirectly, treatment adherence and the overall quality of patient care [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe results of the present feasibility study suggest that the CBT-OP-4 program - as a structured, low-intensity, group-based psychological intervention - can be promisingly integrated into the palliative care of women living with HER2-positive metastatic breast cancer. The significant reductions in psychological distress, depressive symptoms, and stigmatization, alongside the increase in self-compassion, indicate psychological changes that may provide potentially clinically relevant support for psychosocial adaptation to cancer diagnosis as well as cancer treatment. The intervention\u0026rsquo;s favorable acceptability and high practical applicability further reinforce the justification for implementing the program within this particularly vulnerable patient population.\u003c/p\u003e \u003cp\u003eAlthough the small sample size and non-randomized design of the study limit the interpretation of the psychological outcomes, this research provides a valuable foundation for future longitudinal and controlled trials investigating the efficacy and long-term effects of the CBT-OP-4 protocol.\u003c/p\u003e \u003cp\u003eTo address the ordering anomaly, we emphasize that the psychological analysis, derived from the other endpoints of the study will be the first to be published, as the primary TAT results have not yet been released. The psychological data are scientifically independent of the primary endpoint and, therefore, their analysis does not compromise the integrity of the main trial findings.\u003c/p\u003e \u003cp\u003eOur findings also support the necessity of the structured integration of psycho-oncological interventions into palliative care, particularly for patients facing significant psychosocial challenges despite extended survival due to targeted therapies.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eCompeting Interests\u003c/h2\u003e \u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThis research study was in part funded by Roche (Magyarorsz\u0026aacute;g) Kft. in the form of investigational drugs and financial support being provided to research site.\u003c/p\u003e \u003cp\u003eWe thank the trial participants and the trial site staff who conducted the studies as well as the leadership of Semmelweis University especially Prof. Dr. B\u0026eacute;la Merkely, rector and Prof. Dr. Attila Szab\u0026oacute;, vice rector.\u003c/p\u003e \u003cp\u003eThe publication was prepared in accordance with Good Publication Practice guidelines (ismpp.org/gpp-2022).\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eSzT and VG conceived the study, and developed the theoretical framework, and were responsible for data collection related to the psychological intervention. BM\u0026Aacute; was responsible for designing and developing the study protocol and operationally led the clinical study procedure. MB was responsible for study coordination, clinical study management and clinical data management. PZs was responsible for patient enrollment. SzT and UR analyzed the data. DM supervised the project. All authors discussed the results.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eWe thank the trial participants and the trial site staff who conducted the studies as well as the leadership of Semmelweis University especially Prof. Dr. B\u0026eacute;la Merkely, rector and Prof. Dr. Attila Szab\u0026oacute;, vice rector.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe datasets generated and/or analyzed during the current study are not publicly available due to the sensitive nature of the clinical and psychological data and the risk of participant re-identification, but are available from the corresponding author on reasonable request and with appropriate ethical approval.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eGLOBOCAN (2020) France: The International Agency for Research on Cancer. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://globocan.iarc.fr\u003c/span\u003e\u003cspan address=\"http://globocan.iarc.fr\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHorr C, Buechler SA (2021) Breast cancer consensus subtypes: A system for subtyping breast cancer tumors based on gene expression. \u003cem\u003eNPJ Breast Cancer\u003c/em\u003e 7:136. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1038/s41523-021-00345-2\u003c/span\u003e\u003cspan address=\"10.1038/s41523-021-00345-2\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWolff AC, Hammond MEH, Hicks DG et al (2018) Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: ASCO/CAP clinical practice guideline update. \u003cem\u003eJ Clin Oncol\u003c/em\u003e 36:2105\u0026ndash;2122. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1200/JCO.2018.77.8738\u003c/span\u003e\u003cspan address=\"10.1200/JCO.2018.77.8738\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAmerican Cancer Society (2024) Targeted drug therapy | Breast cancer treatment. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.cancer.org/cancer/types/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html\u003c/span\u003e\u003cspan address=\"https://www.cancer.org/cancer/types/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSnoek HM, Dijkstra A, van der Sluis F et al (2021) Psychological impact of metastasized cancer: A systematic review of qualitative studies. \u003cem\u003eBMJ Open\u003c/em\u003e 11:e040298. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1136/bmjopen-2020-040298\u003c/span\u003e\u003cspan address=\"10.1136/bmjopen-2020-040298\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Society for Medical Oncology (n.d.) 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This study aimed to conduct a preliminary investigation into the feasibility and psychological outcomes of a low-intensity, group-based cognitive-behavioral therapy intervention (CBT-OP-4) among women receiving palliative care.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA prospective feasibility study was undertaken involving 13 female participants (Mean age\u0026thinsp;=\u0026thinsp;63 years, SD\u0026thinsp;=\u0026thinsp;8.05), all diagnosed with HER2-positive metastatic breast cancer. The four-session CBT-based group intervention targeted key psychological domains. Self-reported measures of distress, depression, anxiety, perceived stigma, self-compassion, and locus of control were administered pre- and post-intervention. Feasibility and acceptability were further examined via semi-structured qualitative interviews and standardized patient satisfaction instruments.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eFollowing the intervention, statistically significant pre\u0026ndash;post reductions were observed in psychological distress, depressive symptoms, and perceived stigma. In parallel, participants demonstrated a significant increase in self-compassion. Overall, the program was rated as highly acceptable, with participants emphasizing the relevance and applicability of the intervention content within their illness context.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eFindings from this preliminary study suggest that the CBT-OP-4 program is a feasible and acceptable psycho-oncological intervention for women with advanced-stage HER2-positive breast cancer receiving palliative care. The results offer initial empirical support for the incorporation of structured, evidence-based psychological interventions into the routine psychosocial management of this patient population\u003c/p\u003e","manuscriptTitle":"Feasibility Study of the Four-Session Cognitive-Behavioral Therapy–based Psychological Intervention Program for Women with HER2-Positive Metastatic Breast Cancer","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-22 12:56:55","doi":"10.21203/rs.3.rs-8595208/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-03-24T23:15:51+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-03-24T22:41:53+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-03-09T12:33:00+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"284026650895392486241864665636092093230","date":"2026-03-04T16:56:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"45882216203008084518455418132477371911","date":"2026-03-02T08:34:56+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-02-17T15:35:53+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-02-17T03:21:21+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-26T02:43:44+00:00","index":"","fulltext":""},{"type":"submitted","content":"Supportive Care in Cancer","date":"2026-01-13T19:05:34+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","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":"a1786632-b415-411c-8c67-7db3d70f1729","owner":[],"postedDate":"February 22nd, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-09T03:23:59+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-22 12:56:55","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8595208","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8595208","identity":"rs-8595208","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}