CTRI Number |
CTRI/2023/09/057537 [Registered on: 13/09/2023] Trial Registered Prospectively |
Last Modified On: |
21/07/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Awareness about breast reconstruction surgery |
Scientific Title of Study
|
Assessing the Awareness and Perception towards breast reconstruction in breast cancer patients planned for mastectomy- a cross-sectional study |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
FARHANUL HUDA |
Designation |
Additional Professor |
Affiliation |
AIIMS Rishikesh |
Address |
Department of Surgery AIIMS Rishikesh
Dehradun UTTARANCHAL 249203 India |
Phone |
9997533211 |
Fax |
|
Email |
farhanul1973huda@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
FARHANUL HUDA |
Designation |
Additional Professor |
Affiliation |
AIIMS Rishikesh |
Address |
Department of Surgery AIIMS Rishikesh
Dehradun UTTARANCHAL 249203 India |
Phone |
9997533211 |
Fax |
|
Email |
farhanul1973huda@gmail.com |
|
Details of Contact Person Public Query
|
Name |
FARHANUL HUDA |
Designation |
Additional Professor |
Affiliation |
AIIMS Rishikesh |
Address |
Department of Surgery AIIMS Rishikesh
Dehradun UTTARANCHAL 249203 India |
Phone |
9997533211 |
Fax |
|
Email |
farhanul1973huda@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Farhanul Huda |
Address |
Department of Surgery AIIMS Rishikesh |
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 Farhanul Huda |
AIIMS Rishikesh |
Department of Surgery AIIMS Rishikesh Dehradun UTTARANCHAL |
9997533211
farhanul1973huda@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
All India Institute of Medical Sciences Rishikesh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Female |
Details |
Females more than 18 years of age diagnosed with Stage I to III BC (AJCC staging, 8th edition) and planned for MRM.
Females giving consent to participate in the study.
|
|
ExclusionCriteria |
Details |
1.Male patients with BC
2.Females with Stage IV ((AJCC staging, 8th edition) BC
3.Females with other concomitant cancers
4.Females with Recurrent or Bilateral cancers
5.Females with a history of psychiatric disease not related to their present diagnosis
6.Females who cannot read or speak English or Hindi (The local language)
7.Females who have already undergone BR before
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Awareness about breast reconstruction surgery |
Baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
reasons for refusing or accepting breast reconstruction surgery |
single time point |
|
Target Sample Size
|
Total Sample Size="148" Sample Size from India="148"
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)
|
20/09/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
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
|
Breast
cancer is the most common cancer affecting women. Mastectomy is still the most
common surgery performed for the treatment of breast cancer. Breast
reconstruction refers to the surgical restoration of the breast following
mastectomy. Reconstruction has a positive impact on breast cancer survivors in
terms of increasing/restoring their self-esteem, confidence, body image, and
social acceptance. Despite these advantages, the rate of breast reconstruction
varies widely and is poor in developing countries as compared to the developed
world. There is very little literature looking into the awareness and
perspectives regarding breast reconstruction in patients afflicted with breast
cancer. At a time when oncoplasty is gaining popularity, we need to get rid of
the misconceptions associated with breast reconstruction and increase its
awareness. The current study is planned to assess the level of awareness about
breast reconstruction and to understand its perception among females with
breast cancer. It is a cross-sectional study that will be conducted over a
period of 12 months on patients with breast cancer scheduled for mastectomy.
The eligible participants will be interviewed face-to-face by asking them
questions from a questionnaire, adapted from published literature on this
topic. This study will help us generate evidence regarding awareness about
breast reconstruction, the reasons for the choices, and myths surrounding
breast reconstruction. |