"Effectiveness of Community Health Workers in Breast Cancer Prevention in Jumla: a Cluster Randomized Trials

NCT06869759 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-03-11

No results posted yet for this study

Summary

Breast cancer is the second most prevalent cancer among Nepali females, accounting for 17.1% of cases and 7.7% of female cancer-related deaths. It is more common in younger, premenopausal women, often diagnosed at advanced stages. Raising awareness through community education is crucial for promoting breast cancer screening, particularly in low-resource settings like Nepal, where clinical breast exams are essential early detection tools. Integrating breast cancer education into the health system can enhance knowledge, encourage screening, and promote healthy behaviors for prevention. Early detection significantly improves treatment outcomes and survival rates.

In remote areas, limited access to advanced detection technologies makes breast self-examination (BSE) the most feasible and cost-effective method, particularly in Jumla. This study evaluates the effectiveness of community health worker-led breast cancer prevention through health promotion and education strategies. It follows PROCTOR's framework and the Health Belief Model (HBM) A mixed-methods design will be employed, incorporating an embedded implementation science approach, a cluster-randomized trial, and mixed-method research. The study population includes married women of Jumla, female community health volunteers (FCHVs), and auxiliary nurse midwives (ANMs). Exclusion criteria include married women ≥20 years old with existing cases of cancer, pregnant or lactating women, FCHVs unable to acquire BSE skills, and untrained ANMs. The sample consists of 90 participants in both intervention and control groups.

Acceptability, Appropriateness, and Feasibility will be assessed using the Acceptability of Intervention Measure (AIM) tool. SOP-based checklists will evaluate fidelity, while FGDs and KIIs will collect qualitative data. Quantitative data will be analyzed using frequency, percentage, mean, and standard deviation. A paired t-test and mixed-effect linear regression will assess effectiveness, while qualitative data will undergo thematic analysis. Findings will be reported per CONSORT guidelines.

Ethical approval will be obtained from the Nepal Health Research Council. Expected outcomes include improved breast cancer knowledge, perception, and screening intention, leading to early detection and reduced prevalence. However, selection bias in cluster trials may limit generalizability.

Conditions

Interventions

BEHAVIORAL

Implementation strategy - Health Promotion and Education-based intervention

Firstly, three broad strategies will be implemented in the intervention arm (use of advisory boards, sensitization, and linkage to care). The advisory board meetings will be held every month to discuss the progress and receive their feedback. Secondly, orientation and capacity building will be done by onsite coaching to community health workers at the health facility level on BSE. Those trained health workers will frequently capacitate FCHVs during monthly meetings. Then, FCHV will visit the community to be aware of BSE as well as they will be involved in a stigma reduction campaign. Sensitization to FCHVs through orientation and capacity building by providing 3 batch training to selected 3 wards, then FCHVs aware and practice the skills of BSE to the recruited participants during home visit and Thirdly, the suspected and identified cases will be linked by strengthening the referral mechanism of the health system and CHWs reminders for follow-up to cases.

Sponsors & Collaborators

  • Karnali Academy of Health Sciences

    lead OTHER

Principal Investigators

  • Bharat Kafle · Karnali Academy of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-25
Primary Completion
2025-08-25
Completion
2025-09-25

Countries

  • Nepal

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06869759 on ClinicalTrials.gov