NCT06869759

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

Active, enrolled NA Last updated 11 March 2025

What this trial tests

NA trial testing Implementation strategy - Health Promotion and Education-based intervention in Breast Cancer in 180 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 August 2024

Primary endpoint
25 August 2025

25 September 2025

Quick facts

Lead sponsor	Karnali Academy of Health Sciences
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	180
Start date	25 August 2024
Primary completion	25 August 2025
Estimated completion	25 September 2025
Sites	1 location across Nepal

Drugs / interventions tested

• Implementation strategy - Health Promotion and Education-based intervention

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Prevention — all drugs for Prevention →

Sponsor

Karnali Academy of Health Sciences

Who can join

20 and older, female only, with Breast Cancer or Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.