Clinical trial NCT06869759: "Effectiveness of Community Health Workers in Breast Cancer Prevention in Jumla: a Cluster Randomized Trials
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Prevention
Keywords: Health Promotion and Education Strategies
Lead sponsor: Karnali Academy of Health Sciences
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: The implementation outcome will be measured by: Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE).
timeFrame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
measure: Adoption
timeFrame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
measure: Appropriateness
timeFrame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
measure: Feasibility of implementing FCHV induced breast-self examination
timeFrame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
measure: Fidelity
timeFrame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
measure: Effectiveness
timeFrame: From date of randomization, baseline data collection within 2 weeks, and endline 2 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jumla
country: Nepal
facility: Karnali Academy of Health Sciences, Jumla, Karnali, Nepal
state: Karnali
Study officials:
affiliation: Karnali Academy of Health Sciences
name: Bharat Kafle
role: PRINCIPAL_INVESTIGATOR
References: