跳至主要内容
临床试验/CTRI/2026/03/106376
CTRI/2026/03/106376尚未招募不适用

Impact of External Breast Prosthesis on Post-Mastectomy Quality of Life: A Single-Institution Study from a Tertiary Care Centre in Southern India

Ganti Sravya Deepika1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2026年4月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
53
试验地点
1

研究概览

简要总结

Breast cancer is the most common malignancy among women in India with mastectomy often being the primary treatment While breast reconstruction is an option many Indian women opt for external breast prostheses EBP due to financial constraints lack of awareness and limited access to reconstruction services However studies indicate that a significant proportion of post mastectomy patients rely on makeshift alternatives impacting their quality of life QoL

This prospective observational study aims to evaluate the impact of EBP on post mastectomy QoL using the BREAST Q questionnaire at AIIMS Mangalagiri The study will assess changes in QoL scores before and after EBP use along with factors influencing adherence and barriers to access The study duration is for one year The calculated sample size is 53 Post mastectomy women aged 18 years and above and at least three months post operation with no prior reconstruction will be included Patients will complete BREAST Q before EBP use then at three months and six months after application Eligible patients will be counselled on EBP benefits fitted with prostheses and followed up through outpatient visits or telephonic assessments BREAST Q scores will be analysed to determine improvements in psychosocial and physical well being Statistical analysis will be done using paired t tests or Wilcoxon signed rank test for pre and post intervention comparisons and repeated measures ANOVA for longitudinal QoL assessment at baseline three months and six months Expected outcomes include improved QoL self esteem and body image after EBP use and identification of key barriers to EBP adoption

This study will provide critical evidence to integrate post mastectomy rehabilitation into routine oncology care

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
Female

入选标准

  • Women eighteen years or above who have undergone mastectomy unilateral or bilateral and have completed a minimum of three months postoperative period No prior breast reconstruction or implant-based reconstruction No current use of an external breast prosthesis Willing to use an External Breast Prosthesis provided by the study and participate in followups.

排除标准

  • Active cancer recurrence or metastasis Presence of severe comorbidities affecting Quality of Life measurement Patients who refuse to use a prosthesis even when offered.

研究者

发起方
Ganti Sravya Deepika
申办方类型
Other [Principal Investigator]
责任方
Principal Investigator
主要研究者

Sravya Deepika Ganti

All India Institute of Medical Sciences, Mangalagiri

研究点 (1)

Loading locations...

相似试验