Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 - 2024

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It is essential to comprehend how radiation affects breast cancer survivors’ quality of life to improve their overall treatment and well-being. The quality of life among breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), affiliated with the University Of Datta Meghe Institute Of Higher Education and Research (DMIHER), Sawangi, following radiation therapy is examined in this study during the years 2023–2024. Methods This observational cross-sectional study will be conducted in the Department of Radiotherapy of AVBRH associated with DMIHER, the hospital is situated in the state of Maharashtra, in India, from 2023 to 2024. We will select Breast cancer patients registered in AVBRH at the Radiotherapy department from Jan 2023 to October 2023 and receive treatment in the form of radiotherapy; chemotherapy and radiotherapy. The study will be observational and cross-sectional. This research will take approximately six months. Questionnaires will be distributed on the spot to patients and phone interviews for distant patients will be conducted using an interview checklist. Discussion The study is expected to contribute significantly to the existing body of knowledge by delving into specific challenges and experiences of breast cancer survivors post-radiotherapy, particularly within the context of a rural healthcare setting. By concentrating on this group, the study will contribute to the body of existing knowledge by offering a deeper view of the variables influencing the quality of life in breast cancer survivors. The knowledge gathered from this research will be extremely helpful in understanding the complex effects of radiation therapy on the physical, psychological, and social aspects of survivors’ quality of life. 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F1000Research 2024, 13 :555 ( https://doi.org/10.12688/f1000research.151256.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 - 2024 [version 1; peer review: 1 approved with reservations] Induni Nayodhara Weerarathna https://orcid.org/0009-0007-6996-8270 1 , anurag luharia https://orcid.org/0000-0001-6051-1636 2 , ashish uke 3 , Gaurav Mishra 4 Induni Nayodhara Weerarathna https://orcid.org/0009-0007-6996-8270 1 , anurag luharia https://orcid.org/0000-0001-6051-1636 2 , ashish uke 3 , Gaurav Mishra 4 PUBLISHED 30 May 2024 Author details Author details 1 Biomedical Sciences, Datta Meghe institute of higher education and reseatch, Wardha, Maharashtra, 442001, India 2 Radiotherapy, Datta Meghe institute of higher edcucation and research, Wardha, Maharashtra, 442001, India 3 Radio oncology, Datta meghe Institute of higher education and research, Wardha, Maharashtra, 442001, India 4 Radio diagnosis, Datta meghe institute of higher education and research, Wardha, Maharashtra, 442001, India Induni Nayodhara Weerarathna Roles: Conceptualization, Formal Analysis, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing anurag luharia Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing ashish uke Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Gaurav Mishra Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Introduction The process of breast cancer treatment, especially radiation therapy, frequently alters patients’ lives significantly. It is essential to comprehend how radiation affects breast cancer survivors’ quality of life to improve their overall treatment and well-being. The quality of life among breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), affiliated with the University Of Datta Meghe Institute Of Higher Education and Research (DMIHER), Sawangi, following radiation therapy is examined in this study during the years 2023–2024. Methods This observational cross-sectional study will be conducted in the Department of Radiotherapy of AVBRH associated with DMIHER, the hospital is situated in the state of Maharashtra, in India, from 2023 to 2024. We will select Breast cancer patients registered in AVBRH at the Radiotherapy department from Jan 2023 to October 2023 and receive treatment in the form of radiotherapy; chemotherapy and radiotherapy. The study will be observational and cross-sectional. This research will take approximately six months. Questionnaires will be distributed on the spot to patients and phone interviews for distant patients will be conducted using an interview checklist. Discussion The study is expected to contribute significantly to the existing body of knowledge by delving into specific challenges and experiences of breast cancer survivors post-radiotherapy, particularly within the context of a rural healthcare setting. By concentrating on this group, the study will contribute to the body of existing knowledge by offering a deeper view of the variables influencing the quality of life in breast cancer survivors. The knowledge gathered from this research will be extremely helpful in understanding the complex effects of radiation therapy on the physical, psychological, and social aspects of survivors’ quality of life. READ ALL READ LESS Keywords Quality of life (QoL), breast cancer, post radiotherapy, impact, assessment Corresponding Author(s) Induni Nayodhara Weerarathna ( [email protected] ) Close Corresponding author: Induni Nayodhara Weerarathna Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Weerarathna IN et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The author(s) is/are employees of the US Government and therefore domestic copyright protection in USA does not apply to this work. The work may be protected under the copyright laws of other jurisdictions when used in those jurisdictions. How to cite: Weerarathna IN, luharia a, uke a and Mishra G. Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 - 2024 [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :555 ( https://doi.org/10.12688/f1000research.151256.1 ) First published: 30 May 2024, 13 :555 ( https://doi.org/10.12688/f1000research.151256.1 ) Latest published: 30 May 2024, 13 :555 ( https://doi.org/10.12688/f1000research.151256.1 ) Introduction Background Breast cancer is the most common malignancy among women globally. It has now surpassed lung cancer as the leading cause of global cancer incidence in 2020, with an estimated 2.3 million new cases, representing 11.7% of all cancer cases. In India, the incidence has increased significantly, almost by 50%, between 1965 and 1985. 1 Current trends point out that a higher proportion of the disease is occurring at a younger age in Indian women, as compared to the West. The overall 5-year survival rate appears to be 95%, 92%, 70%, and only 21% for stage I, II, III and IV patients respectively. 2 The survival rate of patients with breast cancer is poor in India as compared to Western countries due to earlier age of onset, late stage of disease at presentation, delayed initiation of definitive management, and inadequate/fragmented treatment. 1 Indian Breast cancer patients especially those from poor socio-economical backgrounds have advanced physical symptoms and psychosocial distress that adversely affect their QoL. Their experiences with breast cancer vary but may include diagnosis, initial treatment, managing genetic risk and psychological effects, unique concerns associated with non-invasive breast cancer, recurrence, finishing treatment and returning to normal life, survivorship, and palliative care for advanced cancer. 3 Many cancer patients may have questions regarding their condition as they adjust to their diagnosis, but they may be afraid to ask their doctor. Many women who receive a breast cancer diagnosis for the first time may experience shock, fear, anxiety, and sadness. 4 Psychological therapies could assist patients in managing their feelings and treating any mental illnesses that may arise, such as anxiety, panic, and depressive disorders. Some cancer patients could be reluctant to express their worries about their condition and course of treatment, and they might be much more reluctant to bring up any psychological issues they might experience. Although patients want their medical professionals to ask about their everyday activities and general well-being, this may not always happen. 4 In the past, objective tumor response and survival have been used to evaluate the effectiveness of cancer treatments. Throughout the past ten years, there have been two significant shifts in the way that cancer is treated. The first is the understanding that receiving cancer therapy depends on the patient’s mental health. 5 Another is the use of psychosocial and QoL surveys to gauge their level of well-being. Psychosocial and emotional issues have been studied in intervention studies with breast cancer patients for the past 25 years. A key clinical and research topic has been how breast cancer treatment affects a patient’s quality of life. Psychosocial workers, nurses, and oncologists all that QOL is a crucial factor to take into account during and after cancer treatment. 6 Physical functioning, psychological well-being (including anxiety and depression levels), and social support are some of the categories that make up quality of life. Evaluations of QOL have applications in diagnosis, prognosis prediction, assessment, patient monitoring, clinical decision-making, communication, and therapy. Additional applications include developing system interventions, assigning funds for research and resources, educating medical staff, and cutting expenses. 3 The course of treatment for breast cancer is determined by the specific subtype of the disease and the extent to which it has spread to lymph nodes (stages II or III) or other regions of the body (stage IV). The treatment mainly consists of Surgery, Chemotherapy (Neoadjuvant, adjuvant, and palliative), Radiation therapy, and hormonal therapy. It lessens the chance of recurrence in the breast and the tissues around it. 7 Researchers use a variety of assessment instruments to assess the QoL in patients with breast cancer receiving radiation therapy. There are two primary categories for disease-specific measures, such as the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) and the Functional Assessment of Cancer Therapy-Breast (FACT-B). The Short Form Health Survey (SF-36) and EuroQol-5D (EQ-5D) are examples of generic instruments. 8 Crucial factors to take into account are validity, which guarantees accurate measurement, and dependability, which guarantees consistent results. Good test-retest reliability and internal consistency have been shown by generic instruments like the EQ-5D and SF-36 across a range of cancer groups. Disease-specific measures like the FACT-B and EORTC QLQ-BR23, which show strong correlations with clinical indicators and sensitivity to changes in health status after therapy, are further examples of construct validity. In the context of AVBRH, Sawangi breast cancer patients, these validated metrics offer a robust foundation for assessing radiation therapy’s impact on quality of life. Imran M et al. This cross-sectional study aims to determine the quality of life (QoL) differences between various groups and evaluate the QoL of a cohort of breast cancer patients at the Oncology Department, King Abdulaziz University Hospital (KAUH), King Abdulaziz University (KAU), Jeddah, Saudi Arabia (SA). Breast cancer survivors’ quality of life was evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core30 and BR23 (EORTC QLQ-C30 & BR23). They conclude that Patients with breast cancer who came to their institute had improved quality of life in terms of functional and symptom ratings, as well as overall global health status. Patients’ physical functioning scores were the lowest and their social functioning scores were the greatest. 9 Bener A. et al. their study aimed to assess the psychometric properties of the Arabic version of the European Organization for Research and Treatment of Cancer (EORTC) general QoL questionnaire (QLQ-C30) for breast cancer patients in Qatar. The conclusion is that the Qatari Arabic version of the EORTC QLQ-C30 showed acceptable psychometric properties, which is a reliable and valid instrument, that can be used by oncologists. 10 Kluthcovsky AC et al. conducted research to assess fatigue and quality of life in disease-free breast cancer survivors about a sample of age-matched women with no cancer history and to explore the relationship between fatigue and quality of life. A cross-sectional research comprising 202 Brazilian breast cancer survivors who were free of disease and had undergone treatment at two sizable hospitals was carried out. The patients were compared to age-matched women who visited a primary healthcare center and had no history of cancer. We measured the quality of life and fatigue using the World Health Organization Quality of Life Instrument (WHOQOL-BREF) and the Piper Fatigue Scale-Revised, respectively. Additionally, clinical and sociodemographic characteristics were acquired. The findings of this study highlight the importance of assessing fatigue and quality of life in breast cancer survivors. 11 Aim This study aim is to analyze the quality of life (QoL) among breast cancer patients undergoing treatment at Siddharth Gupta Memorial Cancer Hospital through a QoL questionnaire. Objectives • Examine the overall effects of breast cancer on patients’ physical, social, and psychological well-being at Siddharth Gupta Memorial Cancer Hospital. • Investigate variations in patients’ well-being throughout different stages of treatment. • Identify unique challenges breast cancer patients face in performing daily tasks and maintaining physical functioning. • Utilize quality-of-life questionnaires to subjectively evaluate patients’ psychological and emotional experiences during and after treatment. • Explore patients’ strategies for managing emotional distress during their cancer journey. • Assess the availability and impact of social support networks on patients’ quality of life, including relationships with friends, family, and the larger community. • Analyze how different treatment modalities and their side effects influence patients’ overall health. • Propose improvements to healthcare protocols in Siddharth Gupta Memorial Cancer Hospital based on findings. • Evaluate the effectiveness of administrative and social support services in enhancing patients’ overall quality of life and satisfaction with care. Methods This observational cross-sectional study will be held in the department of Acharya Vinoba Bhave Rural Hospital associated with Datta Meghe Institute of Higher Education and Research (DMIHER), and the hospital is situated in the state of Maharashtra, in India, between the time frame of January 2023 to October 2023. The study will be conducted after obtaining written consent from breast cancer patients (or caregivers) who have received the form of radiotherapy (chemotherapy and radiotherapy) from Acharya Vinoba Bhave Rural Hospital. EORTC QoL questionnaires C30 and BR23 are to be used along with required consent from patients and caregivers. The study registered on 02 February 2024 in institutional ethical committee of the Datta Meghe Institute of Higher Education and Research, DMIMS (DU)/IEC/2023/215. Inclusion criteria and exclusion criteria Inclusion criteria : • Patients must be literate and capable of either writing or speaking in Hindi or Marathi, the regional languages. • Alternatively, if the patient is not literate, their caregiver must possess a sufficient level of literacy. • Participants must have undergone radiotherapy treatment for breast cancer. • Patients’ medical records should include details of surgery, chemotherapy, and radiotherapy. • Patients or their caregivers must be accessible via telephone for data collection regarding aspects related to their quality of life post-radiotherapy. Exclusion criteria : • Patients falling outside the specified time frame of the study period (2023 to 2024) will not be considered for inclusion • Illiterate patients and those unable to speak or write Hindi or Marathi, the regional languages • Patients for whom essential medical data, including details of surgery, chemotherapy, and radiotherapy, are unavailable, will not be included in the study Bias : • Possibility of recollection bias • study does not consider patients who received only surgery and chemotherapy (NACT, adjuvant, and palliative) • Potential cultural differences impacting participant experiences Variables : For this study, we will use different kinds of data such as patient demographic data, clinical outcome, and Outcome variables. The outcome variables are finally associated with the outcome of the study. Demographic variables : • Gender • Age • Material status • Associate illness • Education • Current occupation • Menopausal status • Monthly/salary income • Religion Clinical outcome : • Biopsy date • TNM stage • Stage of the disease • Surgery date • Type of surgery • Pathological TNM • Chemo (NACT/ADJ/PALL) • Chemo regimen • Herceptin • Hormonal therapy • RT registration date • Simulation date • Plan • Technique (3D CRT/IMRT) • RT start date and end date Outcome variables : • The European Organization for Research and Treatment of Cancer Quality of Life cancer-specific questionnaire (EORTC QLQ-C30) • The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life breast cancer-specific questionnaire (QLQ-BR23) Sample size calculation : We are expecting approximately 60-150 patients treated with adjuvant radiotherapy for breast cancer. Type of sampling : All the files registered for radiation oncology for the treatment of breast cancer in the specified period. The patients will be selected through a systematic sampling method. Formula used: n ≥ 2 ( Z 1 − α / 2 + Z 1 − β ) 2 ( δ Difference / ) 2 + Z 1 − α / 2 2 2 Primary variable Overall health score assessed by EORTC QLQ-C-30 score Assumption Z 1 − α / 2 = 0.01 = 2.58, Power (1- β) at 99% = 2.34 Mean difference (δ difference) = 26.66 We considered standard deviation difference σ Difference = 28.65 Required sample size = 59 Referred article: Ref. 12 . Study procedure The case report form including the patient’s name, age, sex, marital status, associate illness, education, current occupation, menopausal status, number of children, monthly salary income, religion, and history of treatment including biopsy date, ER/PR/HER2, TNM stage, etc will be noted using their previous diagnosis files and by communicating with patients. The Case reform form is having 31 questions including patients’ demographic data and past diagnosis. It will be filled by the examiner. After an explanation of the study, the principal researcher will answer the participants’ questions and present the consent form for signature. The patients who are coming to the hospital for their follow-up will complete the questionnaires. If the patient is unable to fill or answer the questions caregiver will fill the questionnaires. The patients will complete the following questionnaires: • The European Organization for Research and Treatment of Cancer Quality of Life cancer-specific questionnaire (EORTC QLQ-C30) to assess HRQoL. 13 • The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life breast cancer-specific questionnaire (QLQ-BR23) to assess HRQoL Distant patients who are eligible for this study will be contacted through telephone conversation and the examiner will ask their demographic data and questions related to QoL using interview checklists. Expected outcomes 1. Identification of specific psychosocial Challenges: The study is expected to identify shared psychosocial issues among breast cancer survivors post-radiation therapy. 2. Improved integration of mental health support services: By identifying common psychosocial issues, the study may facilitate the integration of mental health support services within the oncology department and hospital settings. 3. Informed treatment decision-making: Insights into how different treatment modalities affect quality of life can inform treatment decisions. 4. Enhanced healthcare protocols: The study results can inform the development of healthcare protocols and interventions tailored to the needs of breast cancer survivors. 5. Holistic understanding of survivorship: The study is expected to provide a comprehensive understanding of the variables affecting breast cancer survivors’ quality of life after radiation treatment in a rural Indian environment. Statistical analysis All the results will be calculated using R software version 4.3. Descriptive statistics will be tabulated and will be presented in mean, median, and std. deviation for quantitative measurement & in frequency and percentage for qualitative data. Missing values will be incorporated by applying mean and median values using the imputation method. The outcome variable will be tested for finding the significant association of quality of life with factors associated using chi-square analysis at ordinal or nominal data more than two categories and Fisher Exact’s test for two category ordinal data or nominal data. For quantitative measurement with t-test or ANOVA at parametric values and mann-whitney or kruscal-wallis test for non-parametric data for two or more two variables. The effect of confounding variables will be analyzed using multivariate analysis. Ethical statement The proposal of the study was approved by the institutional ethical committee of the Datta Meghe Institute of Higher Education and Research (approved on 2nd February 2024; reference number: DMIHER (DU)/IEC/2023/215). Informed written consent will be obtained from each participant. Dissemination After the completion of the study, we will publish it in an indexed journal. Study status The study is yet to start. After the publication of the protocol, we will start recruitment in the study. Discussion Significant new information about the quality of life among breast cancer survivors in rural India following radiation treatment was provided by the study. Important discoveries demonstrated the complex effects of radiation therapy on the physical, psychological, and social well-being of survivors. Numerous characteristics of quality of life were shown to be significantly correlated with demographic factors such as age, socioeconomic level, and educational background. Other characteristics that were found to have an impact were clinical variables such as cancer stage, treatment modes, and treatment outcomes. Moreover, coping mechanisms, social support systems, and psychological well-being were found to be important factors that influence survivors’ overall quality of life. The results of the study offer important new perspectives on the complex effects of radiation treatment on the quality of life of Indian rural breast cancer survivors. The study’s observational methodology and reliance on self-reported data call for care when interpreting the findings, but they do highlight the intricate interactions between clinical, psychosocial, and demographic factors that influence survivors’ well-being. The results contribute to a nuanced understanding of survivorship experiences and inform the creation of focused treatments to improve patient care and support by taking into account the study’s objectives, limitations, and the larger body of evidence. The study’s generalizability to other groups and contexts may be restricted, even though it provides insightful information about the experiences of breast cancer survivors treated at AVBRH, Sawangi. The application of study findings may be impacted by variations in socioeconomic conditions, cultural norms, and healthcare infrastructure in various locations. The study, however, provides a framework for examining survivor experiences and guiding healthcare practices to better address the needs of breast cancer survivors globally. This paves the way for further research in comparable rural healthcare settings. Author contribution Induni Nayodhara Weerarathna: Conceptualization, Methodology, Writing original draft, Visualization. Anurag Luharia: Conceptualization, Methodology, Writing- protocol and editing, Visualization, Supervision Ashish Uke: Conceptualization, Writing- protocol and editing, Supervision Gaurav Mishra: Conceptualization, Methodology, Writing- protocol and editing, Visualization, Supervision Data availability Underlying data No data are associated with this article. Extended data Repository Name: Zenodo. File Name: STROBE checklist for Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 – 2024. DOI: 10.5281/zenodo.11178076 URL: https://zenodo.org/records/11178076 File name: Patient consent form for Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 – 2024. DOI: 10.5281/zenodo.11191397 URL: https://zenodo.org/records/11191397 File name: Case report for Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 – 2024. DOI: 10.5281/zenodo.11191477 URL: https://zenodo.org/records/11191477 File name: QOL questionnaires for Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 – 2024. DOI: 10.5281/zenodo.11191505 URL: https://zenodo.org/records/11191505 Licence: CC BY 4.0 Software availability: Zenodo Reporting guidelines: STROBE – Cross-sectional. References 1. Mehrotra R, Yadav K: Breast cancer in India: Present scenario and the challenges ahead. World J Clin Oncol. 2022; 13 : 209–218. PubMed Abstract | Publisher Full Text | Free Full Text 2. Maurya AP, Brahmachari S: Current Status of Breast Cancer Management in India. Indian J Surg. 2021; 83 : 316–321. Publisher Full Text 3. Perry S, Kowalski TL, Chang C-H: Quality of life assessment in women with breast cancer: benefits, acceptability and utilization. Health Qual Life Outcomes. 2007; 5 : 24. PubMed Abstract | Publisher Full Text | Free Full Text 4. Board I of M (US) and NRC (US) NCPHewitt M, Herdman R, et al. : Psychosocial Needs of Women with Breast Cancer. Meeting Psychosocial Needs of Women with Breast Cancer. US: National Academies Press; 2004. 5. Khan FA, Akhtar SS, Sheikh MK: Cancer Treatment - Objectives and Quality of Life Issues. Malays J Med Sci MJMS. 2005; 12 : 3–5. PubMed Abstract 6. Lu Q, Chen L, Shin LJ, et al. : Improvement in Quality of Life and Psychological Well-being Associated with a Culturally Based Psychosocial Intervention for Chinese American Breast Cancer Survivors. Support Care Cancer Off J Multinatl Assoc Support Care Cancer. 2021; 29 : 4565–4573. PubMed Abstract | Publisher Full Text | Free Full Text 7. Breast cancer: Accessed: December 22, 2023. Reference Source 8. Chen F, Ma LY, Zhao C, et al. : Quality of Life Assessment in Patients with Breast Cancer Receiving Radiation Therapy: A Prospective Study. Int J Radiat Oncol Biol Phys. 2022; 114 : e457. Publisher Full Text 9. Imran M, Al-Wassia R, Alkhayyat SS, et al. : Assessment of quality of life (QoL) in breast cancer patients by using EORTC QLQ-C30 and BR-23 questionnaires: A tertiary care center survey in the western region of Saudi Arabia. PLoS One. 2019; 14 : e0219093. PubMed Abstract | Publisher Full Text | Free Full Text 10. Bener A, Alsulaiman R, Doodson L, et al. : An assessment of reliability and validity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 among breast cancer patients in Qatar. J Fam Med Prim Care. 2017; 6 : 824–831. PubMed Abstract | Publisher Full Text | Free Full Text 11. Kluthcovsky ACGC, Urbanetz AA: Fatigue and quality of life in breast cancer survivors: a comparative study. Rev Bras Ginecol E Obstet Rev Fed Bras Soc Ginecol E Obstet. 2015; 37 : 119–126. PubMed Abstract | Publisher Full Text 12. da Silva JGB , Costa DT, Cavalcanti IDL, et al. : Quality of life in women with breast cancer treated at a radiotherapy centre in Caruaru, Pernambuco, Brazil. Can Oncol Nurs J. 2022; 32 : 162–171. PubMed Abstract | Publisher Full Text | Free Full Text 13. EORTC QLQ-C30 Reference Values. EORTC Quality of Life Group: 2008. [accessed 2021-10-21]. Reference Source Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 30 May 2024 ADD YOUR COMMENT Comment Author details Author details 1 Biomedical Sciences, Datta Meghe institute of higher education and reseatch, Wardha, Maharashtra, 442001, India 2 Radiotherapy, Datta Meghe institute of higher edcucation and research, Wardha, Maharashtra, 442001, India 3 Radio oncology, Datta meghe Institute of higher education and research, Wardha, Maharashtra, 442001, India 4 Radio diagnosis, Datta meghe institute of higher education and research, Wardha, Maharashtra, 442001, India Induni Nayodhara Weerarathna Roles: Conceptualization, Formal Analysis, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing anurag luharia Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing ashish uke Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Gaurav Mishra Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 30 May 2024, 13:555 https://doi.org/10.12688/f1000research.151256.1 Copyright © 2024 Weerarathna IN et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The author(s) is/are employees of the US Government and therefore domestic copyright protection in USA does not apply to this work. The work may be protected under the copyright laws of other jurisdictions when used in those jurisdictions. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Weerarathna IN, luharia a, uke a and Mishra G. Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 - 2024 [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :555 ( https://doi.org/10.12688/f1000research.151256.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 30 May 2024 Views 0 Cite How to cite this report: Arndt V, Frick J and Zhu Z. Reviewer Report For: Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 - 2024 [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :555 ( https://doi.org/10.5256/f1000research.165889.r290379 ) The direct URL for this report is: https://f1000research.com/articles/13-555/v1#referee-response-290379 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 09 Jul 2024 Volker Arndt , German Cancer Research Center, Heidelberg, Germany Julian Frick , German Cancer Research Center, Heidelberg, Heidelberg, Germany Zhounan Zhu , German Cancer Research Center, Heidelberg, Heidelberg, Germany Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.165889.r290379 Report This report describes the protocol of a study to assess quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 – 2024. General comments: Funding: ... Continue reading READ ALL Report This report describes the protocol of a study to assess quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 – 2024. General comments: Funding: No information regarding funding is given. Either source of funding or a statement that there is no funding should be added. Title: Given that this is an observational cross-sectional study, words claiming causality (such as “impact”) should be avoided. The title should state that this is a study protocol (the current title is misleading) Introduction: The introduction is very general and does not lead to the specific question of the study. The authors are advised to get to the point more stringently. Para 1, 2 nd sentence: A reference should be added to the statement regarding global incidence. Para 1, 3 rd sentence: This sentence refers to a historic situation 40 years ago. What are the recent trends. Introduction, Para 4: Unclear, why the EORTC QLQ-C30, an instrument to be used in this particular study is not mentioned here. Introduction, Para 5-7: Three individual studies are described in a very detailed way. It is unclear why these three studies are presented in such a prominent way. Suggest to omit them. Aims/Objective: The objectives and study aim should be more concise, less descriptive/explorative. A clear hypothesis is missing. The objectives are too numerous. According to the methods described later in the article, some objectives may not be achievable. For instance, regarding the questionnaire data during and after treatment, the author does not clarify whether the same patients were surveyed at different time points. Additionally, there is no data collected on patients' emotion management strategies, friends and social support, or treatment side effects. Investigating variations in patients’ well-being throughout different stages of treatment requires a longitudinal study with repeated measurements. Different treatment modalities “effect” on the overall health of the patients shall be assessed, but no information is given in the methods how this should be accomplished. Similarly, the evaluation of the effectiveness of administrative and social support services to enhance QoL and satisfaction needs to be outlined in the methods section in more detail. "undergoing treatment" should be changed to "undergoing radiotherapy" to be more precise. Methods The authors state that the has been registered in February 2024 but the first paragraph reads like that the study took place from January to October 2023. It is very unusual for a study to be registered after it has already taken place and reads like the study is already over. Please correct/revise. Inclusion criteria: Female gender is not listed among the inclusion criteria. Will also male breast cancer patients be included? Specific stage and age ranges are not specified. Will cases any age and stage be included? This will increase heterogeneity of the sample and lower the power. Bias Should recollection bias read recall bias? The "s" in "study" at the beginning of the second point should be capitalized. The potential of selection bias and threads by imbalanced study sample should be addressed Variables Demographic Variables If only female breast cancer patients will be included, then there is no need to include gender as covariate What is meant by “associate illness”? Please clearify The discussion section mentions the consideration of cultural norms. This would require that relevant variables need to be included. Furthermore, based on the article's objectives, variables like friends and social support, urban/city, language, support services and insurance should also be considered. Clinical variables (“clinical outcome”) ER/PR/HER2 are not mentioned. Consider including BRCA, histology of the tumour (pathological diagnosis), grading and metastatic sites. Outcome variables need to be specified in more detail (i.e. which scores or items?) Study procedure: Patients who are coming to the hospital for their follow-up will be invited to complete the questionnaires. What about those who are not fit enough to attend the clinic? Will they be lost? The authors suggest different modes of administration (MOA) but should take into account that MOA has impact on patient reported outcome. Expected outcomes The expected outcomes are very ambitious. It is questionable whether they can be achieved. #1: It is unclear how specific needs can be identified if there is neither a specified control group not an operationalization of needs? #3: Specify hypotheses, covariates, required sample size? Sample size calculation The authors state that the required sample size would be 59. Does this mean overall or per group? What are the groups? 59 reads small compared to many others studies and the reviewer's own experience. Consider to adjust for multiple testing given the plethora of scales used in the EORTC LQ-C30. Statistical analyses Statements like “outcome variable will be tested for finding the significant association” reads like a fishing expedition The authors state “The effect of confounding variables will be analyzed using multivariate analysis.”. The reviewer advices that potential confounders should be defined beforehand. This crucial for a study to be useful at all. Once the data have been collected it will be too late to fix it. Is the rationale for, and objectives of, the study clearly described? No Is the study design appropriate for the research question? No Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Epidemiology, HRQOL and Cancer Survivorship Research We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Arndt V, Frick J and Zhu Z. Reviewer Report For: Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 - 2024 [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :555 ( https://doi.org/10.5256/f1000research.165889.r290379 ) The direct URL for this report is: https://f1000research.com/articles/13-555/v1#referee-response-290379 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 30 May 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 30 May 24 read Volker Arndt , German Cancer Research Center, Heidelberg, Germany Julian Frick , German Cancer Research Center, Heidelberg, Germany Zhounan Zhu , German Cancer Research Center, Heidelberg, Germany Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Arndt V et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 09 Jul 2024 | for Version 1 Volker Arndt , German Cancer Research Center, Heidelberg, Germany Julian Frick , German Cancer Research Center, Heidelberg, Heidelberg, Germany Zhounan Zhu , German Cancer Research Center, Heidelberg, Heidelberg, Germany 0 Views copyright © 2024 Arndt V et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Report This report describes the protocol of a study to assess quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 – 2024. General comments: Funding: No information regarding funding is given. Either source of funding or a statement that there is no funding should be added. Title: Given that this is an observational cross-sectional study, words claiming causality (such as “impact”) should be avoided. The title should state that this is a study protocol (the current title is misleading) Introduction: The introduction is very general and does not lead to the specific question of the study. The authors are advised to get to the point more stringently. Para 1, 2 nd sentence: A reference should be added to the statement regarding global incidence. Para 1, 3 rd sentence: This sentence refers to a historic situation 40 years ago. What are the recent trends. Introduction, Para 4: Unclear, why the EORTC QLQ-C30, an instrument to be used in this particular study is not mentioned here. Introduction, Para 5-7: Three individual studies are described in a very detailed way. It is unclear why these three studies are presented in such a prominent way. Suggest to omit them. Aims/Objective: The objectives and study aim should be more concise, less descriptive/explorative. A clear hypothesis is missing. The objectives are too numerous. According to the methods described later in the article, some objectives may not be achievable. For instance, regarding the questionnaire data during and after treatment, the author does not clarify whether the same patients were surveyed at different time points. Additionally, there is no data collected on patients' emotion management strategies, friends and social support, or treatment side effects. Investigating variations in patients’ well-being throughout different stages of treatment requires a longitudinal study with repeated measurements. Different treatment modalities “effect” on the overall health of the patients shall be assessed, but no information is given in the methods how this should be accomplished. Similarly, the evaluation of the effectiveness of administrative and social support services to enhance QoL and satisfaction needs to be outlined in the methods section in more detail. "undergoing treatment" should be changed to "undergoing radiotherapy" to be more precise. Methods The authors state that the has been registered in February 2024 but the first paragraph reads like that the study took place from January to October 2023. It is very unusual for a study to be registered after it has already taken place and reads like the study is already over. Please correct/revise. Inclusion criteria: Female gender is not listed among the inclusion criteria. Will also male breast cancer patients be included? Specific stage and age ranges are not specified. Will cases any age and stage be included? This will increase heterogeneity of the sample and lower the power. Bias Should recollection bias read recall bias? The "s" in "study" at the beginning of the second point should be capitalized. The potential of selection bias and threads by imbalanced study sample should be addressed Variables Demographic Variables If only female breast cancer patients will be included, then there is no need to include gender as covariate What is meant by “associate illness”? Please clearify The discussion section mentions the consideration of cultural norms. This would require that relevant variables need to be included. Furthermore, based on the article's objectives, variables like friends and social support, urban/city, language, support services and insurance should also be considered. Clinical variables (“clinical outcome”) ER/PR/HER2 are not mentioned. Consider including BRCA, histology of the tumour (pathological diagnosis), grading and metastatic sites. Outcome variables need to be specified in more detail (i.e. which scores or items?) Study procedure: Patients who are coming to the hospital for their follow-up will be invited to complete the questionnaires. What about those who are not fit enough to attend the clinic? Will they be lost? The authors suggest different modes of administration (MOA) but should take into account that MOA has impact on patient reported outcome. Expected outcomes The expected outcomes are very ambitious. It is questionable whether they can be achieved. #1: It is unclear how specific needs can be identified if there is neither a specified control group not an operationalization of needs? #3: Specify hypotheses, covariates, required sample size? Sample size calculation The authors state that the required sample size would be 59. Does this mean overall or per group? What are the groups? 59 reads small compared to many others studies and the reviewer's own experience. Consider to adjust for multiple testing given the plethora of scales used in the EORTC LQ-C30. Statistical analyses Statements like “outcome variable will be tested for finding the significant association” reads like a fishing expedition The authors state “The effect of confounding variables will be analyzed using multivariate analysis.”. The reviewer advices that potential confounders should be defined beforehand. This crucial for a study to be useful at all. Once the data have been collected it will be too late to fix it. Is the rationale for, and objectives of, the study clearly described? No Is the study design appropriate for the research question? No Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Epidemiology, HRQOL and Cancer Survivorship Research We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. reply Respond to this report Responses (0) Arndt V, Frick J and Zhu Z. Peer Review Report For: Assessment and impact in quality-of-life post radiotherapy in breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, 2023 - 2024 [version 1; peer review: 1 approved with reservations] . F1000Research 2024, 13 :555 ( https://doi.org/10.5256/f1000research.165889.r290379) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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