Quality of life in breast cancer patients
- Conditions
- Malignant neoplasm of breast of unspecified site,
- Registration Number
- CTRI/2024/09/073535
- Lead Sponsor
- Dr Madhuri Taranikanti
- Brief Summary
Introduction: Breast cancer is one of the most commonly diagnosed malignancy in women and is the leading cause of death worldwide. Breast cancer alone is responsible for 30% of newly diagnosed cancer
cases in women with a high probability that one in eight women will develop breast cancer in their lifetime. It has also been established that 14% of cancer-related deaths are attributed to breast cancer (1,2). Cancers in general demonstrate a higher fatigue score and poorer quality of life attributed to physical, psychological and social factors and (3,4). Breast cancer is a distinctive entity as it hampers the physical appearance of the women besides living with the fear of outcome of cancer including recurrence and death (5,6). The choice of treatment like contralateral mastectomy, conservative breast surgery or immediate reconstruction after
mastectomy can also significantly influence the quality of life in survivors (7,8). Depression, fertility-issues, economic burden and other social issues can also affect quality of life (9,10,11). Different tools have been used to assess the quality of life of patients. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires—Core-30 and Breast-23 (QLQ-C30 and QLQ-BR23)—are valid and reliable tools to assess QoL in breast cancer survivors (12,13,14,15). The present study intends to assess the QoL of breast cancer patients as data from this part of the world is scare and there is an ever increasing incidence of
breast cancer patients in India.
Aims and Objectives:
The aim of the study will be to administered to EORTC QLQ-C30 and BR23 questionnaires to breast cancer patients visiting and obtaining treatment at the Oncology Department of ESIC Medical College and Hospital, Hyderabad with the objective to differentiate QoL among
different groups of breast cancer patients in varying stages of the disease
2. To explore the association of different variables with the domains of QoL.
Methodology:
A total of ----Breast cancer patients, managed at ESIC Medical College and Hospital Oncology Unit, with their diagnosis established at least 6 months ago will be eligible to participate in the study. European Organization for Research and Treatment of Cancer Quality of Life
QuestionnaireCore-30 and Breast-23 (EORTC QLQ-C30 & -BR23) will be administered to the patients. Written consent will be obtained from all the participants on a consent form, the purpose of the study was briefly explained to the participants and the strict confidentiality of the
participants’ information was maintained.
The EORTC QLQ-C30 is a 30-item self-administered cancer specific questionnaire designed to measure QOL in the cancer population. The assessment is comprised of nine domains (physical, role, cognitive, emotional, social, fatigue, pain, nausea and vomiting [43]. The EORTC QLQ-BR23 is a 23-item self-administered breast cancer specific questionnaire, usually administered with the EORTC QLQ-C30, designed to measure QOL in the breast cancer population at various stages and with patients with differing treatment modalities. The assessment is comprised of five domains (body image, sexuality, arm symptoms, breast
symptoms, and systemic therapy side effects) [44].
Statistical Analysis:
The results will be expressed as percentages and a ‘t’ test will be performed to know the significance.
Expected Outcome/Hypothesis: Assessment of QoL of Breast cancer patients has the potential to help in clinical decision making, triage patients, referral for treatable issues which are normally overlooked and provide accurate status of their functioning and well being. The study results might help in managing cancer patients better.
The results are also expected to influence healthcare providers to agree that QoL assessments are valuable in practice and hence, increase the acceptablility among them for its routing use. Also, patient acceptability is expected to be good as the contents of the questionnaires are
sensitive to the needs of the patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 175
Women who have been diagnosed with histologically proven breast cancers.
Women with any other cancers.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of quality of life post breast cancer. 9 months: Analysis of the study to assess quality of life
- Secondary Outcome Measures
Name Time Method Implement these findings for better patient care. 1 year: Including these points as part of management protocol.
Trial Locations
- Locations (1)
ESIC Medical College, Sanathnagar, Hyderabad
🇮🇳Hyderabad, TELANGANA, India
ESIC Medical College, Sanathnagar, Hyderabad🇮🇳Hyderabad, TELANGANA, IndiaDr Madhuri TaranikantiPrincipal investigator8008366030madhuri.tarani@gmail.com