Assess the well-being of individuals who have undergone breast surgery and chemotherapy for breast cancer, and identify the factors influencing their well being.
- Conditions
- Malignant neoplasm of breast,
- Registration Number
- CTRI/2024/01/061374
- Lead Sponsor
- Moly Thomas
- Brief Summary
This study is a descriptive study to assess the quality of life and identify its predictors among patients with breast cancer after surgical and chemotherapy treatment. After obtaining permission from administrative authority, subjects will be selected according to the inclusion and exclusion criteria from selected oncology departments of tertiary hospitals in Kerala. Informed consent will be obtained from patients with breast cancer receiving surgical and chemotherapy treatments, after a detailed explanation of aim, procedure and participant’s role in the study.The investigator collects the baseline data with the help of a structured questionnaire and the clinical data will be collected by the researcher by using medical records and interview techniques. Then researcher will administer Quality of life questionnaire EORTC QLQ - C30 and EORTC QLQ-BR 23 after completing chemotherapy treatment, ie after finishing four or more cycles of chemotherapy. The primary outcome will be assess the quality of life and identify its predictors among patients with breast cancer after surgical and chemotherapy treatment.Secondary outcome will be compare the quality of life between patients undergoing breast conservation and mastectomy surgery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 422
Inclusion criteria Patients with breast cancer receiving surgical and chemotherapy treatment who are 1.willing to participate in the study 2.Pathologically proven breast carcinoma 3.Planned for receiving minimum 4cycles of chemotherapy before/ after/before and after breast surgery 4.able to speak, read and write Malayalam 5.between the age group of 18 and 70 years.
Exclusion criteria Patients who are 1.critically ill 2.with metastasis 3.psychiatric or cognitive disorders 4.reported hearing problems.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the quality of life and to determine the predictors of quality of life among patients with breast cancer after surgical and chemotherapy treatment After completing surgical and chemotherapy treatment
- Secondary Outcome Measures
Name Time Method Compare the quality of life between patients undergoing breast conservation and mastectomy surgery After completing surgical and chemotherapy treatment
Trial Locations
- Locations (1)
Amala Institute of Medical Sciences
🇮🇳Thrissur, KERALA, India
Amala Institute of Medical Sciences🇮🇳Thrissur, KERALA, IndiaMoly ThomasPrincipal investigator9633425247molythomas171989@gmail.com