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

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

Inclusion criteria and exclusion criteria

Inclusion criteria:

Exclusion criteria:

Bias:

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:

Clinical outcome:

Outcome variables:

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:

Primary variable Overall health score assessed by EORTC QLQ-C-30 score

Assumption $Z_{\mathbf{1}-\alpha /2}$ = 0.01 = 2.58, Power (1- β) at 99% = 2.34

Mean difference (δ difference) = 26.66

We considered standard deviation difference ${\mathit{\sigma }}_{\mathit{\text{Difference}}}$ = 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:

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

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.