| CTRI Number |
CTRI/2025/12/098879 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
An Educational Program to Increase Breast Cancer Awareness Among Women in Rural Puducherry |
|
Scientific Title of Study
|
An Quasi-experimental study on breast cancer awareness and breast self-examination practise among rural women in Pondicherry |
| 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 Jennifer Rachel |
| Designation |
Postgraduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of Community Medicine, Aarupadai Veedu Medical College and Hospital
Pondicherry
PONDICHERRY
600507
India |
| Phone |
9345167750 |
| Fax |
|
| Email |
jenrache1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Valmurthy |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of Community Medicine, Aarupadai Veedu Medical College and Hospital, Pondicherry
Pondicherry
PONDICHERRY
600507
India |
| Phone |
9585247637 |
| Fax |
|
| Email |
sudhavalmurthy2025@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jennifer Rachel |
| Designation |
Postgraduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of Community Medicine, Aarupadai Veedu Medical College and Hospital, Kirumampakkam
Pondicherry
PONDICHERRY
600507
India |
| Phone |
9345167750 |
| Fax |
|
| Email |
jenrache1994@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College and Hospital |
| Address |
Aarupadai Veedu Medical College and Hospital, Kirumampakkam, Puducherry, 607403 |
| 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 Jennifer Rachel |
Department of Community Medicine, Aarupadai Veedu Medical College and Hospital |
Kirumampakkam,607402
Pondicherry
PONDICHERRY |
9345167750
jenrache1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, Aarupadai Veedu Medical College and Hospital, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Structured teaching program |
A HEALTH EDUCATION on breast cancer and breast self-examination steps for 50 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women between the age group 18 and 60 years
Women residing in the rural field practice area of AVMCH
|
|
| ExclusionCriteria |
| Details |
Women having history of breast malignant diseases
Women with history of surgical and medical management for breast cancer
Pregnant and Lactating women
Women relocating during the study period
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of structured teaching program amongst rural women on the awareness of breast cancer and assess the practice of Breast self-examination after 1 month and 6 months of intervention |
Baseline and 1 month post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between knowledge and socio-demographic characteristics |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
An interventional study with one group pre and posttest design will be conducted among women in the age group between 18 and 60 years who are residing in the rural field practice area of Aarupadai Veedu Medical College and Hospital, Puducherry. After obtaining IRC and IEC clearance, 100 participants meeting the inclusion criteria will be selected by systematic random sampling. A structured questionnaire will be used to assess the knowledge of breast cancer and breast self-examination practice at baseline and at 1 month post-intervention. |