LONG TERM PATIENT REPORTED OUTCOME OF SURGERY IN NON METASTATIC BREAST CANCER PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- The long-term quality of life in patients who underwent mastectomy without reconstruction and breast conservation surgery for carcinoma breast using BREAST Q questionnaire.
研究概览
简要总结
The study aims to investigate the patient-reported outcomes of surgery in non-metastatic breast carcinoma patients who have undergone either breast conservation surgery or mastectomy without reconstruction. Using the validated BREAST-Q questionnaire, a patient-reported outcome measure , the research intends to evaluate and compare the long-term quality of life outcomes in Indian patients. The study will involve a sample size of 210 participants. Through quantitative assessment of BREAST-Q scores and qualitative insights from patient interviews, the research seeks to provide comprehensive insights into the physical, psychosocial, and sexual well-being outcomes post-surgery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 20-65 years who underwent surgery for non-metastatic breast cancer 3 to 6 year ago from their date of enrollment in this study.
- •No clinical evidence of recurrence at the time of inclusion.
- •Patients should have completed their education till 8th grade.
- •Patients who are comfortable in understanding and speaking either Hindi or English.
排除标准
- •Patients who have developed metastasis at the time of study.
- •Patients having concomitant secondary malignancy during study period.
- •Patients having musculoskeletal disorders that affecting their quality of life.
- •Patients who do not give consent to participate.
- •Patient with psychiatry illness that is limiting the comprehension of questionnaire.
结局指标
主要结局
The long-term quality of life in patients who underwent mastectomy without reconstruction and breast conservation surgery for carcinoma breast using BREAST Q questionnaire.
时间窗: Baseline
次要结局
- 1.Comparison of long-term quality of life following breast conservation surgery and mastectomy using BREAST Q questionnaire.
研究者
Dr Suhani
All India Institute of Medical Sciences, New Delhi