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CTRI Number  CTRI/2025/03/082092 [Registered on: 10/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   External breast prosthesis study 
Scientific Title of Study   Study on role of External breast prosthesis in psycho-social experiences of breast cancer survivors who underwent mastectomy 
Trial Acronym  External breast prosthesis study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Heena Shaikh 
Designation  Scientific officer C 
Affiliation  ACTREC- Tata Memorial Centre 
Address  205-A, Second Floor, Paymaster Shodhika, ACTREC-Tata Memorial Centre Kharghar, Navi Mumbai-410210 Contact: 022-6873 5000 Extn: 5483

Raigarh
MAHARASHTRA
410210
India 
Phone  02268725000  
Fax  02268725000  
Email  hshaikh@actrec.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Heena Shaikh 
Designation  Scientific officer C 
Affiliation  ACTREC- Tata Memorial Centre 
Address  205A, Second Floor, Paymaster Shodhika, ACTREC-Tata Memorial Centre Kharghar, Navi Mumbai-410210 Contact: 022-6873 5000 Extn: 5483

Raigarh
MAHARASHTRA
410210
India 
Phone  02268725000  
Fax  02268725000  
Email  hshaikh@actrec.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Heena Shaikh 
Designation  Scientific officer C 
Affiliation  ACTREC- Tata Memorial Centre 
Address  205A, Second Floor, Paymaster Shodhika, ACTREC-Tata Memorial Centre Kharghar, Navi Mumbai-410210 Contact: 022-6873 5000 Extn: 5483

Raigarh
MAHARASHTRA
410210
India 
Phone  02268725000  
Fax  02268725000  
Email  hshaikh@actrec.gov.in  
 
Source of Monetary or Material Support  
Heavy Water Board, 5th Floor, Vikram Sarabhai Bhavan, Anushakti Nagar, Mumbai, Maharashtra 400094 
 
Primary Sponsor  
Name  ACTREC 
Address  ACTREC, Tata Memorial Centre Kharghar, Navi Mumbai-410210 Contact: 022-6873 5000 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Heena Shaikh  ACTREC Tata Memorial Centre  Medical Administration, 205A, Pay Master Shodhika
Raigarh
MAHARASHTRA 
9029007867

hshaikh@actrec.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee 3   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  For part one of the study
1. Patients who have used external breast prosthesis (either silicon or cotton) for at least two months.
For part two of the study
2. Patients who underwent mastectomy at least 15 days before enrolment with fully healed wounds.
3. Patients who have not used prosthesis and are willing to use Prosthesis.
4. Patients who are cognitively sound.
 
 
ExclusionCriteria 
Details  1. Patients who have been treated with Radiotherapy within 30 days of enrolment.
2. Patients who underwent Breast conservation surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the impact of mastectomy on a breast cancer patient’s body image, confidence, and self-esteem.
2. To evaluate the variables impacting breast cancer patient’s/survivor’s body image, confidence and self-esteem.
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.
4. To compare the experience with Silicon and Cotton prosthesis. 
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
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

    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.

 
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