| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
|
|
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. |