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NCT Number: NCT06869759

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Prevention Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karnali Academy of Health Sciences, Jumla, Karnali, Nepal

Jumla, Karnali, Nepal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implementation strategy - Health Promotion and Education-based intervention

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.

Primary outcomes

  1. The implementation outcome will be measured by: Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE).

    Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention

    Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE). The following indicators will measure this: participants' attitudes toward BSE, perception scores measured in the mean score and SD, and the percentage of women satisfied with BSE practices.

  2. Adoption

    Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention

    Adoption will be measured by the percentage of CHW and FCHVs willing to adopt BSE. It will also be measured by the extent to which FCHVs are eager and able to integrate BSE activities into their existing roles and responsibilities.

  3. Appropriateness

    Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention

    Appropriateness will be measured using indicators of the extent to which CNMP is suitably suited to the cultural, social, and economic context and aligned with the needs and preferences of the target population.

  4. Feasibility of implementing FCHV induced breast-self examination

    Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention

    Feasibility will be measured by assessing the practicality and ease of implementing FCHV in CNMP, quantified through the percentage of health facilities equipped with necessary resources, including training materials and equipment, as well as the proportion of FCHV implementation strategies successfully adopted

  5. Fidelity

    Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention

    Fidelity will be measured by evaluating the extent to which FCHVs and HFs adhere to the prescribed guidelines and protocols for BSE screening and referral, monitoring the consistency of FCHV discussed in the HMG meeting across different communities, and evaluating the extent to which women adhere to the prescribed guidelines for BSE.

  6. Effectiveness

    Time frame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention

    Effectiveness outcomes will be measured using the following indicators: Perception, attitude, knowledge, coverage of BSE screening, and Follow-up rates for positive cases.

Sponsors and collaborators

Lead sponsor

Karnali Academy of Health Sciences

Other

Registry information

Official study title

Effectiveness of Community Health Workers Induced Prevention of Breast Cancer by Community Health Promotion and Education Implementation Strategies in Jumla - a Cluster Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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