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

NCT ID: NCT06869759

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-25
• Study Completion Date: 2025-09-25

Brief 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

Breast Cancer; Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

Implementation strategy - Health Promotion and Education-based intervention

Intervention Type: BEHAVIORAL

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.

Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Karnali Academy of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Bharat Kafle

Fellowship

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bharat Kafle

Role: PRINCIPAL_INVESTIGATOR

Karnali Academy of Health Sciences

Locations

Karnali Academy of Health Sciences, Jumla, Karnali, Nepal

Jumla, Karnali, Nepal

Countries

Nepal

Other Identifiers

BC2024

Identifier Type: -

Identifier Source: org_study_id