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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The implementation outcome will be measured by: Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Married women >= 20 years of age group women of CNMP Jumla,
- •FCHV, those who can read, write, and understand, and
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Implementation strategy - Health Promotion and Education-based intervention (Behavioral)
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.
结局指标
主要结局
The implementation outcome will be measured by: Acceptability (attitude and perception of women toward BSE and satisfaction levels of the individuals who perform BSE).
时间窗: 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.
Adoption
时间窗: 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.
Appropriateness
时间窗: 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.
Feasibility of implementing FCHV induced breast-self examination
时间窗: 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
Fidelity
时间窗: 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.
Effectiveness
时间窗: 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.
次要结局
未报告次要终点
研究者
Bharat Kafle
Fellowship
Karnali Academy of Health Sciences