| CTRI Number |
CTRI/2025/11/097967 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Community-Based Intervention on Breast and Cervical Cancer Awareness, Screening Practice and Screening Uptake, among Rural Women in selected districts of West Bengal. |
|
Scientific Title of Study
|
Effectiveness of Community-Based Intervention on Breast and Cervical Cancer Awareness, Screening Practice and Screening Uptake, among Rural Women in selected districts of West Bengal: A Mixed Method Approach |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna Kundu |
| Designation |
Reader and PhD Student |
| Affiliation |
West Bengal Government College of Nursing, IPGMER and SSKM Hospital |
| Address |
Department of Obstetrical Nursing, Room No. 202, West Bengal Government College of Nursing, IPGME&R and SSKM Hospital,244 AJC Bose Road, Kolkata
Kolkata WEST BENGAL 700020 India |
| Phone |
8900171571 |
| Fax |
|
| Email |
aparna.mconmpl2024@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sinjita Dutta |
| Designation |
Associate Professor and Co Guide |
| Affiliation |
IPGMER and SSKM Hospital,Kolkata |
| Address |
Department of Community Medicine, IPGME&R and SSKM Hospital,244 AJC Bose Road, Kolkata
Kolkata WEST BENGAL 700020 India |
| Phone |
9830470649 |
| Fax |
|
| Email |
sinjita@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Aparna Kundu |
| Designation |
PhD Student |
| Affiliation |
West Bengal Government College of Nursing, IPGMER and SSKM Hospital |
| Address |
Department of Obstetrical Nursing, Room No. 202, West Bengal Government College of Nursing, IPGME&R and SSKM Hospital,244 AJC Bose Road, Kolkata
Kolkata WEST BENGAL 700020 India |
| Phone |
8900171571 |
| Fax |
|
| Email |
aparna.mconmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Sub centers under Budge Budge II Block, Department of Health and Family Welfare, Government of West Bengal |
|
|
Primary Sponsor
|
| Name |
Aparna Kundu |
| Address |
West Bengal Government College of Nursing, IPGMER and SSKM Hospital,244 AJC Bose Road, Kolkata-700020 |
| Type of Sponsor |
Other [Self] |
|
|
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 Aparna Kundu |
LB Dutta Rural Hospital |
Room No-2,Department-NCD Clinic,LB Dutta Rural Hospital , Budge Budge II Block, Muchisa South Twentyfour Parganas WEST BENGAL |
8900171571
aparna.mconmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy women without breast and cervical cancer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Teaching About Breast and Cervical cancer |
Awareness Camp, Telephonic Interaction, Leaflet |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Rural Women aged 30-65 years who can speak in Bengali and Hindi.
2. Women who have not done regular screening for both cervical and breast cancer.
|
|
| ExclusionCriteria |
| Details |
1. Rural Women who are critically ill.
2. Women with immunosuppressant drugs.
3. Rural Women diagnosed with cervical cancer or breast cancer.
4. Within 6 weeks of delivery or abortion.
5. Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase the number of breast and cervical cancer screenings, BSE, CBE and mammography for breast cancer, Pap smear for cervical cancer. |
The screening record for breast and cervical cancer will be assessed at baseline,4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Increase the practice of screening for breast and cervical cancer.
2. Increase the reporting of breast and cervical cancer at health facilities.
3. Increase the number of referral cases of breast and cervical cancer. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="412" Sample Size from India="412"
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)
|
29/12/2025 |
| 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="3" 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 is a mixed-method study to assess the Effectiveness of Community-Based Intervention on Breast and Cervical Cancer Awareness, Screening Practice, and Screening Uptake, among Rural Women in selected districts of West Bengal. In the qualitative phase, Focus Group Discussion(FGD) will be done among the community health workers and rural women separately to identify barriers and facilitators of breast and cervical cancer screening. A total of 6-8 FGDs is planned. Based on the facilitators and barriers, a community-based intervention will be developed. Before the implementation of the community-based intervention, rural women will be assessed for awareness, screening practice, and screening uptake of breast and cervical cancer. Awareness will be assessed using the AWACAN (Standardized Tool), and practice will be evaluated using a checklist. The community-based intervention will be implemented for the sample through an awareness camp, by distributing teaching materials in the local language. One to interaction after the community-based intervention, awareness, screening practice, and screening uptake will be assessed to identify the effect of the Community-Based Intervention at one month and 3 months. To assess the screening uptake, medical records of the women will be checked for the Clinical Breast Examination(CBE), and mammography for breast cancer screening, and Visual Inspection (VIA) and Pap smear for cervical cancer screening up to one year. These screening tests the women will do for screening as per their age requirement. |