跳至主要内容
临床试验/CTRI/2025/03/082092
CTRI/2025/03/082092尚未招募不适用

Study on role of External breast prosthesis in psycho-social experiences of breast cancer survivors who underwent mastectomy

ACTREC1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年4月20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
300
试验地点
1
主要终点
1. To evaluate the impact of mastectomy on a breast cancer patient’s body image, confidence, and self-esteem.

研究概览

简要总结

Mastectomy causes an alteration in the appearance of the breast which affects women’s self-image and femininity that can lead to anxiety and depression of breast cancer cases is increasing in developing countries like India. There are very few studies describing effect of Mastectomy on Women and experiences of women using external breast prosthesis after mastectomy, in India. The cost of different types of prosthesises vary widely starting from a few hundred rupees to 7000-8000. Many women refuse to use a breast prosthesis as they cannot afford. Also, some women find it uncomfortable to wear an external prosthesis. The authors could not find any data on the preference and affordability of the Indian women requiring external breast prosthesis. Therefore, we propose to conduct a mix method observational study using both qualitative and quantitative methods to evaluate the effect of mastectomy and use of external breast prosthesis after the mastectomy on Indian women.

Quantitative study

To understand experiences of breast cancer patients, post mastectomy and how use of prosthesis impact such experiences. The interviews will be conducted in-person in the hospital. Hopwood’s body image scale will be used to conduct the satisfaction survey of patients using prosthesis .

Part 1: 100 breast cancer patient/survivors who have used cotton prosthesis and 100 patients who have used silicon prosthesis for at least 2 months will be interviewed.

Part 2: 100 breast cancer patients who has underwent mastectomy but has not used the prosthesis and are willing to use cotton prosthesis will be enrolled. The same 100 breast cancer patients will be interviewed again after 2 or more months of using the cotton breast prosthesis.

·         Qualitative study

The qualitative study will be conducted in minimum 10 survey participants or until responses start to repeat in each of the following groups:

Patients who used silicon prosthesis (Part 1)

Patients who used cotton prosthesis (Part 1)

Patients who underwent mastectomy but not using EBP (Part 2)

Patients using cotton prosthesis for at least two months. (Part 2)

The qualitative study uses in-depth, semi-structured interviews based on a comprehensive questionnaire. Interviews, conducted privately and lasting 60-90 minutes, will be audio-recorded and transcribed for analysis. Ethical guidelines, including informed consent and confidentiality, will be strictly followed. Qualitative study is incorporated for an in-depth understanding impact of EBP in breast cancer patients who underwent mastectomy.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • For part one of the study
  • Patients who have used external breast prosthesis (either silicon or cotton) for at least two months.
  • For part two of the study
  • Patients who underwent mastectomy at least 15 days before enrolment with fully healed wounds.
  • Patients who have not used prosthesis and are willing to use Prosthesis.
  • Patients who are cognitively sound.

排除标准

  • Patients who have been treated with Radiotherapy within 30 days of enrolment.
  • Patients who underwent Breast conservation surgery.

结局指标

主要结局

1. To evaluate the impact of mastectomy on a breast cancer patient’s body image, confidence, and self-esteem.

时间窗: 1. Baseline details will be collect after mastectomy and before use of prosthesis. | 2. Another evaluation will be done 2 months after using external breast prosthesis

2. To evaluate the variables impacting breast cancer patient’s/survivor’s body image, confidence and self-esteem.

时间窗: 1. Baseline details will be collect after mastectomy and before use of prosthesis. | 2. Another evaluation will be done 2 months after using external breast prosthesis

3. To evaluate the role and effect of external breast prosthesis after mastectomy on impact body image, confidence and self-esteem of the breast cancer patient/survivor based on hopwoods score.

时间窗: 1. Baseline details will be collect after mastectomy and before use of prosthesis. | 2. Another evaluation will be done 2 months after using external breast prosthesis

4. To compare the experience with Silicon and Cotton prosthesis.

时间窗: 1. Baseline details will be collect after mastectomy and before use of prosthesis. | 2. Another evaluation will be done 2 months after using external breast prosthesis

次要结局

未报告次要终点

研究者

发起方
ACTREC
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Heena Shaikh

ACTREC- Tata Memorial Centre

研究点 (1)

Loading locations...

相似试验