FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092632 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   A study to improve knowledge and awareness about cervical and breast cancer through educational sessions for young adults and women in India 
Scientific Title of Study   CAPTURE: Cancer Awareness and screening Promotion Through Utilization of community Resources and their Empowerment. 
Trial Acronym  CAPTURE  
Secondary IDs if Any  
Secondary ID  Identifier 
-  NIL 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyotsna Coelho 
Designation  Assistant Professor of OBG 
Affiliation  Father Muller Medical College Hospital 
Address  OBG Clinic, First Floor- Father muller medical college Hospital, Father Mullers Rd, Kankanady, Mangaluru, Karnataka 575002, India

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9483459824  
Fax    
Email  jyotsnacoelho@fathermuller.in  
 
Details of Contact Person
Scientific Query  
Name  Jyoshma Preema Dsouza 
Designation  Post doctoral Fellow 
Affiliation  University of Luxembourg 
Address  9 Av de la fonte, Maison du Nombre, Second Floor, Room 0245100 Belval, Esch sur ALzette, Luxembourg
(Permanent Indian address) Kerebail House Permannur Post Thokkottu, Mangalore, 575017
Not Applicable
N/A
4364
Other 
Phone  621760721  
Fax    
Email  jyoshma.dsouza@uni.lu  
 
Details of Contact Person
Public Query  
Name  Jyotsna Coelho 
Designation  Assistant Professor of OBG 
Affiliation  Father Muller Medical College Hospital 
Address  OBG Clinic, First Floor- Father muller medical college Hospital, Father Mullers Rd, Kankanady, Mangaluru, Karnataka 575002, India

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9483459824  
Fax    
Email  jyotsnacoelho@fathermuller.in  
 
Source of Monetary or Material Support  
Father Muller Medical College Hospital (Even if no grant is exchanged, institution will provide in-kind support (e.g., research team time, intervention delivery, analysis)). 
Kasturba Medical College, Mangalore (Even if no grant is exchanged, institution will provide in-kind support (e.g., research team time, intervention delivery, analysis)). 
 
Primary Sponsor  
Name  University of Luxembourg 
Address  2 Av.de LUniversite l, Esch-Belval Esch-sur-Alzette 4365-Luxembourg 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Dr Jyoshma Dsouza  Kerebail House, Permannur Post Thokkottu , Mangalore 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Abhishek Krishna  Mangalore  Room No 6 & 7, Comprehensive Oncology OPD, Ground Floor, KMC Hospital Attavar, Attavar, Mangalore - 575001 (Attavar) Site: Community outreach.
Dakshina Kannada
KARNATAKA 		 9008783820

abhishek.krishna@manipal.edu 
Abhishek Krishna  Mangalore  Room No 6 & 7, Comprehensive Oncology OPD, Ground Floor, KMC Hospital Attavar, Attavar, Mangalore - 575001 (Attavar) Site: Community outreach and KMC Hospital for cancer patients(assessing cancer delay)
Dakshina Kannada
KARNATAKA 		 9008783820

abhishek.krishna@manipal.edu 
Jyotsna Coelho  Mangalore  Father Muller Medical College Department of Obstetrics and Gynaecology, Father Muller Road, Kankanady, Mangalore – 575002, Karnataka, India Study site:Outreach (Community) and father Muller medical college Hospital for "Cancer delay assessment among cancer patients" and "Nurse-led educational intervention in hospital)
Dakshina Kannada
KARNATAKA 		 9483459824

jyotsnacoelho@fathermuller.in 
Jyotsna Coelho  Mangalore  Father Muller Medical College Department of Obstetrics and Gynaecology, Father Muller Road, Kankanady, Mangalore – 575002, Karnataka, India Study site:Outreach (Community)
Dakshina Kannada
KARNATAKA 		 9483459824

jyotsnacoelho@fathermuller.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE(FMIEC)  Approved 
KASTURBA MEDICAL COLLEGE MANGALORE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  And Patients diagnosed with breast(C50) and cervical cancer(C53), that are physically, mentally amd emotionally able to and willing to participate on a voluntary basis. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Educational Material  Details: Wherever feasible, a comparator arm will be included in parallel across the three sectors (community, university, and hospital). Participants in the comparator group will receive only the existing routine educational pamphlets on breast and cervical cancer and available screening services, as distributed by local health authorities or NGOs. These participants will not receive any structured, theory-based, or interactive educational session. This arm will help assess the added value of the structured intervention compared to routine information-sharing practices. 
Intervention  Tailored Theory based Educational intervention  Strategy: this intervention is designed to be delivered in 3 ways in following settings, to test its feasibility. Details: This is a multi-sector, non-clinical, educational intervention informed by the health behaviour theory based framework. The intervention aims to address psychosocial and system-related barriers to breast and cervical cancer screening uptake across three distinct sectors. Each sector implements a tailored version of the educational program: 1. Community Sector Target group: Women aged 30–60 Delivery mode: Group sessions using flipcharts, PowerPoint, and video modules Delivered by: Gynecologist and public health expert Tools: Pre/post questionnaires, FGDs, and informational handouts on screening centers Follow-up: Screening uptake tracked at 3 and 6 months based on referrals.Screening uptake monitored through handout-based identification at screening centers 2. University Sector Target group: Students aged 20–27 Delivery mode: Lecture/discussion with educative vedio and pictures; (optional educational music concert-based on feasibility to promote awareness) Delivered by: Gynecologist and researcher Focus: Improving awareness among young adults about HPV prevention and motivating family referrals (mother/aunt) for cervical and breast cancer screening. Follow-up: university student Referred women’s screening tracked at 3 and 6 months.Screening uptake monitored through handout-based identification at screening centers 3. Hospital Sector (Nurse-led) Target group: Women aged 30–60 visiting hospital Delivery mode: One-on-one flipchart-based sessions (10 minutes) Delivered by: Trained nurses and nursing students Tools: Pre/post questionnaires, informational handouts Follow-up: Screening uptake monitored through handout-based identification at screening centers Each intervention follows a standardized structure but is adapted to the context and target group of the sector. No clinical tests or procedures are involved. The intervention focuses on modifying knowledge, attitudes, and intention to screen, with follow-up to assess voluntary uptake of breast and cervical cancer screening.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Cross sectional Survey in community(Phase 1): Men and women in general population and in university college, Physically and mentally healthy, able to provide consent, knows local language will be include in the participation in survey. The survey will assess knowledge , general beliefs and attitude towards health related practices and choices, knowledge about cancer and cancer screening.

PHASE2-Educational Intervention (in community):
An educational intervention will target women aged 30-60 years though community organizations that provide consent. Women will be invited through announcements. Those illing to voluntarily participate will be included.

Phase 2-Educational intervention (in university college):This phase will invite students(males and females) to participate in cancer awareness intervention. Those willing to participate will be included in the study.

Educational intervention in (hospital settings): Women aged 30-60 years attending hopsitals for reasons will be approached by trained Nursing students and those willing to participate, know the language, provide consent will be included.

Assessing cancer delay diagnosis: Individuals admitted or attending hospital, diagnosed with cervical or breast cancer will be approached and consent will be obtained. Those willing to participate will be included to collect information through a interviewer administered survey. Participants will be included irrespective of age. 
 
ExclusionCriteria 
Details  Individuals physically or mentally challenged, those unable to provide consent, or in terminal stage with palliative care will not be included.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. At least 60% of participants in the intervention group will demonstrate an improvement in knowledge scores from baseline to post-intervention.

 		 T0 – Baseline:
Before the intervention (for knowledge, beliefs, and attitudes)

T1 – Immediately Post-Intervention:
After the intervention (to assess improvement in knowledge and attitude using post-test form)

 
 
Secondary Outcome  
Outcome  TimePoints 
2. Atleast 50% women attending the awareness campaign will voluntarily seek screening for breast and cervical cancer.  T2 – Follow-up at 3 and 6 Months Post-Intervention:
To assess number of actual screening uptake among participants who received screening awareness with handouts/pamphlets. 
 
Target Sample Size   Total Sample Size="2785"
Sample Size from India="2785" 
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)   01/09/2025 
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="2"
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  

Title:
CAPTURE: Cancer Awareness and screening Promotion Through Utilization of community Resources and their Empowerment

Brief Summary:

CAPTURE is a multi-site implementation research project aimed at improving breast and cervical cancer screening uptake in India. The study will identify barriers to screening and implement theory-based educational interventions across three sectors: community-based organizations, academic institutions, and tertiary hospitals. It will be conducted over 24 months, from November 2025 to November 2027 (Inititaion based on HMSC approval obtained), led by the University of Luxembourg in collaboration with Father Muller College of Nursing and Kasturba Medical College, Mangalore. Ethical approvals have been obtained from all participating institutions.

The study includes two main phases. In Phase 1, barriers to screening uptake and early diagnosis will be assessed using the Barrier Assessment Questionnaire for Screening Uptake (BAQSU), developed based on integrated behavioral models including the Health Belief Model, Theory of Planned Behavior, and Theory of Care Seeking Behavior, structured using the DOST framework. This tool will be administered to three target groups: men and women aged 30 to 60 in the community, university students aged 20 to 25, and patients diagnosed with breast or cervical cancer in hospitals, to explore delay in diagnosis and treatment.

In Phase 2, sector-specific educational interventions will be implemented. In the community, educational camps will be delivered using lectures, flipcharts, and video modules led by gynecologists and public health experts. In university settings, students will receive video-based sessions followed by expert-led discussions and creative reinforcements such as music concerts. In hospitals, nurses will deliver short one-on-one awareness sessions using flipcharts for women visiting outpatient departments. Each session will be followed by the distribution of informational handouts with referral information to free screening centers. Screening behavior will be followed up at 3 and 6 months post-intervention.

The primary objective is to assess the demographic, psychosocial, and system-related barriers to cancer screening across the three sectors, and to develop and evaluate tailored educational interventions targeting these barriers. Secondary objectives include measuring behavior change and motivation for screening at follow-up and refining tools such as the BAQSU and educational content based on participant and implementer feedback.

It is expected that 60 percent of intervention participants will show improved knowledge and attitudes post-intervention, and that 50 percent of eligible or referred women will undergo screening within 3 to 6 months. The study will not collect any clinical samples. Only self-reported knowledge, attitudes, and behavioral intentions will be assessed. No personal identifying data will be collected, and informed consent will be obtained from all participants. Study sites will be finalized only after obtaining permission from local authorities. All data will be anonymized. The project has obtained all necessary ethical approvals, and formal collaborations have been signed between the institutions involved.


 
Close