| CTRI Number |
CTRI/2025/07/090604 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
WHAT WOMEN WANT- The factors influencing a women choice of breast surgery and the role of shared decision making in breast cancer management. |
|
Scientific Title of Study
|
WHAT WOMEN WANT- A prospective study of the factors influencing a women choice of breast surgery and the role of shared decision making in breast cancer management. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalaka Joshi |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no 1207, Homi Bhabha Building, Tata Memorial Hospital Dr Ernest Borges Road Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
drjoshishalaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Vijaykumar |
| Designation |
Senior Resident, Department of Breast Surgical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no 1207, Homi Bhabha Building, Tata Memorial Hospital Dr Ernest Borges Road Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
lakshmi.v3692@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalaka Joshi |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no 1207, Homi Bhabha Building, Tata Memorial Hospital Dr Ernest Borges Road Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
drjoshishalaka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Fund Tata Memorial Hospital Dr. Ernest Borges Marg Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Shalaka Joshi |
Tata Memorial Centre |
Room no 103/104 Breast Private OPD Tata Memorial hospital, Dr. Ernest Borges Road, Parel.
Mumbai
MAHARASHTRA |
02224177198
drjoshishalaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Not Applicable |
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
All women planned for surgery for breast cancer including oligometastatic and post neo-adjuvant chemotherapy will be included in the study. |
|
| ExclusionCriteria |
| Details |
Metastatic patients will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the concordance between optimal surgical plan decided by surgical team, and the final surgical procedure chosen by the patients. |
The questionnaire will be taken at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NIL
|
NIL |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
15/07/2025 |
| 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
|
The proposed study aims to study the concordance between optimal
surgical plan decided by surgical team, and the final surgical procedure chosen
by the patients. Further it aims to document factors for non-compliance of the
planned procedure.
|