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

Karnali Academy of Health Sciences

Status: Active, not recruiting

Conditions: Prevention; Breast Cancer

Treatments: Behavioral: Implementation strategy - Health Promotion and Education-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06869759

BC2024

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Married women >= 20 years of age group women of CNMP Jumla,
• FCHV, those who can read, write, and understand, and
• ANM

Exclusion criteria

• Married women >= 20 years age group women who had a positive existing case,
• Pregnant and lactating women of CNMP Jumla,
• FCHV those who cannot acquire the minimum skill of breast self-examination,
• ANM who untrained for BSE.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Arm Description: Clusters will be based on the municipality's wards, to measure the effectiveness of implementation outcomes. There are nine wards in the study site, three of which will be selected for intervention group. Thirty samples will be obtained from each randomly selected cluster of intervention.

Treatment:

Behavioral: Implementation strategy - Health Promotion and Education-based intervention

Control Arm

No Intervention group

Description:

Arm Description: Thirty samples will be obtained from each randomly selected cluster of control group who would not be given any intervention, this group consist of 90 participants. The usual work done by the health system of Nepal (i.e: PEN package); after the end line, will also capacitate the control group by radio jingle after seven month of intervention. A mass campaign will be conducted on the process and importance of BSE by airing a radio jingle on local FM.