| CTRI Number |
CTRI/2025/12/098394 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Training Program to Improve Early Detection of Breast Cancer Among Community Women in Rishikesh |
|
Scientific Title of Study
|
Development, Validation, and Evaluation of the effectiveness of a motivational interviewing training module for early detection of Breast cancer among community women in Rishikesh, India: A Mixed-Method 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 |
Radhika Yadav |
| Designation |
PhD scholar |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of community medicine ,AIIMS rishikesh, 5th floor ,virbhadra road,249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7983668307 |
| Fax |
0135-2462963 |
| Email |
25yradhika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Meenakshi khapre |
| Designation |
Additional professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
015303, Department of community medicine ,AIIMS rishikesh, 5th floor ,virbhadra road,249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8275395006 |
| Fax |
0135-2462963 |
| Email |
drmeenaxikhapre15@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Radhika Yadav |
| Designation |
PhD scholar |
| Affiliation |
AIIMS Rishikesh |
| Address |
SR room , department of community medicine, 5th floor, AIIMS,Rishikesh,Virbhadra road
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7983668307 |
| Fax |
0135-2462963 |
| Email |
25yradhika@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Radhika Yadav |
| Address |
SR room , department of community medicine, 5th floor, AIIMS,Rishikesh,Virbhadra road,Uttranchal,249203 |
| Type of Sponsor |
Other [i have applied for fund for my project but approval is waited] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meenakshi khapre |
prateetnagar raiwala |
Primary health care (primary hospital) Raiwala Rishikesh raiwala
Dehradun
UTTARANCHAL |
8275395006
0135-2462963
drmeenaxikhapre15@ymail.com |
| Dr Meenakshi khapre |
Primary health care (primary hospital) Raiwala Rishikesh |
SR room,primary health care (PHC)khand gaanv 1, raiwala , rishikesh
Dehradun
UTTARANCHAL |
827595006
0135-2462963
drmeenaxikhapre15@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| All india institute of medical sciences rishikesh institutional ethics committee |
Approved |
| All india institute of medical sciences rishikesh institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
will give health education and will screen them for Breast cancer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional style health education will be given to small groups of women |
conventional style health education will be given to small groups of women and then will be invited for free breast screening camp then we will compare the attendance rates of both groups
|
| Intervention |
motivational interviewing based counselling will be given to group of 3 women at a time |
Phase 1: Assess Motivators and Barriers through Focus Group Discussions (FGDs), preparation of the module accordingly
Phase 2: Implementation of the MI module in the selected community
These phases will be achieved by following steps:
Phase 1
Step 1: FGD with community
Step 2: Preparation of the MI module
Step 3: Expert and face validation of the module
Step 4: Incorporate the revisions in the module as per feedback
Phase 2
Step 5: Pre-test of knowledge, practice and attitude related to breast cancer and screening
Step 6: Implementation of the MI module
Step 7: Post-test of knowledge, practice, and attitude related to breast cancer and screening after 2 months of intervention.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Women aged 30-60 years who are non-pregnant, non-lactating
2.Not diagnosed for breast cancer.
3.Not participated in any breast cancer prevention or screening program in the last 1 year
4.Residing in the area for the last one year
|
|
| ExclusionCriteria |
| Details |
o Individuals with significant psychological conditions affecting their ability to participate.
o Individuals who have had breast cancer in the past 5 years, and those who have undergone therapy
o Participants who do not give consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of study participants who attend breast cancer screening camp within two months after the intervention in the Motivational Interviewing (MI) training group compared with the conventional health education group. |
at the screening camps within 2 months of intervention Proportion of study participants who attend breast cancer screening camp within two months after the intervention in the Motivational Interviewing (MI) training group compared with the conventional health education group.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean change in knowledge, attitude, & practice (KAP) scores regarding breast cancer, breast self-examination, & breast cancer screening from baseline to two months post-intervention among community women exposed to the MI training module compared with those receiving conventional health education.
2.Proportion (prevalence) of women with suspected breast cancer identified during screening camps in both the groups . |
1.within two months of intervention
2.after 2 months |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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)
|
01/03/2026 |
| 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
|
This study aims to develop, validate, and evaluate the effectiveness of a Motivational Interviewing (MI) based training module for early detection of breast cancer among community women in Haridwar district, Uttarakhand, India. The study will be conducted in three phases using a mixed-method design. In Phase I, focus group discussions and expert inputs will be used to develop the MI-based training module. In Phase II, the module will be validated by subject experts using structured validation forms. In Phase III, the effectiveness of the module will be evaluated through a quasi-experimental pre-test and post-test design with intervention and control groups. The intervention group will receive motivational interviewing based health education sessions, while the control group will receive conventional health education on breast cancer awareness. Outcomes will include changes in knowledge, attitude, and practice regarding breast cancer screening and self-breast examination. The study findings will help in developing context-specific behavioral intervention strategies to promote early detection of breast cancer among community women. |