| CTRI Number |
CTRI/2023/08/056684 [Registered on: 21/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Awareness and compliance to performing Breast Self Examination amongst persons undergoing routine mammogram/sonomammogram. |
|
Scientific Title of Study
|
Awareness and compliance to Breast Self Examination amongst persons undergoing mammogram/sonomammogram. |
| 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 Chinmaye Peddisetty |
| Designation |
Junior resident, Department of General surgery |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General surgery, 3rd floor, Smt Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8297723331 |
| Fax |
|
| Email |
peddisetty.kmcmpl20222@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Stanley Mathew |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General surgery, 3rd floor, Smt Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844409900 |
| Fax |
|
| Email |
stanley.mathew@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Badareesh L |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General surgery, 3rd floor, Smt Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8861038876 |
| Fax |
|
| Email |
badareesh.l@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Dean, Kasturba Medical College, Manipal |
| Address |
First Floor, Administrative Block, Kasturba Medical College, Manipal,
Udupi, Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Stanley Mathew |
Kasturba Hospital, Manipal |
Department of General Surgery,
3rd floor,
Smt.Sharadha Madhav Pai OPD building,
Kasturba Hospital,
Manipal 576104
Udupi
KARNATAKA |
9844409900
stanley.mathew@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics committee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (2) ICD-10 Condition: R928||Other abnormal and inconclusive findings on diagnostic imaging of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
All female patients above 18 years of age who have undergone mammogram/sonomammogram in Kasturba hospital or elsewhere. |
|
| ExclusionCriteria |
| Details |
Mammogram/sonomammogram done for acute inflammatory conditions. Mammogram done for patients already treated for breast cancer. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of awareness to Breast Self Examination are measured as variables in the proforma |
At the time of performing mammogram at presentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Level of compliance to Breast Self Examination is measured as variables in the proforma & compared between groups |
At the end of 3 months after index visit for mammogram |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
29/08/2023 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response (Others) - Any regulatory agency or editor / reviewer of a scientific publication
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Data will be provided based on a written request
- For how long will this data be available start date provided 31-08-2026 and end date provided 31-08-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
It is a prospective observational cohort study conducted at Kasturba Hospital, Manipal. A total of 150 patients undergoing mammogram or sonomammogram will be recruited. Written consent will be taken from all the patients willing to participate in the study. Data will be obtained from the medical records regarding clinical examination and mammogram/sonomammogram. Participants will be divided into three groups of fifty each by simple randomization (sealed envelop method). For the first group, Patient Information Brochure is given regarding the BSE and the process is demonstrated by the PI. For the second group, Patient Information Brochure is given regarding the BSE and the process is demonstrated by the PI. In addition to the above the participants in the second group are shown and given access to a video of BSE. For the third group, Patient Information Brochure is given regarding the BSE and the process is demonstrated by the PI. In addition to the above the participants in the third group are shown and given access to a video of BSE. In addition to the above the participants in the third group are contacted over telephone for a monthly reminder to perform BSE. First group : PIB + Demonstration by PI Second group : PIB + Demonstration by PI + Video Third group : PIB + Demonstration by PI + Video + Monthly telephonic reminder All participants are reassessed at the end of 3 months regarding various aspects of BSE using a checklist to look at compliance. All participants will be provided with the same information brochure and video demonstration by the end of the 3 month period. |