MIRERC 060/2025: Leveraging Community Health Workers for the Promotion of Breast Cancer Awareness and Timely Help-Seeking Behaviour (BreCATH-B study), Among Underserved Rural Population in Kenya

A Protocol for a Hybrid Type II Cluster Randomised Controlled Trial.

Abstract

CLINICAL TRIAL SYNOPSIS
OVERALL GOAL: The overarching Aim of the BreCATH-B program is to co-create,
implement, and evaluate a theoretically informed, evidence-based, and culturally-sensitive
breast screening program that enables earlier diagnosis and reduces advanced-stage diagnosis
in an underserved rural population in Kenya. To accomplish this goal, the project will be
guided by several Specific Aims.
Specific Aim 1: Describe contextual facilitators and barriers to the implementation of the
BreCATH-B program from the perspectives of patient partners and stakeholders. This aim
will use mixed methods to explore implementation determinants using the PRISM
framework.
Specific Aim 2: Co-create the BreCATH-B program by adapting an existing evidence-based
intervention (EBI) that has been developed and evaluated in Rwanda through a randomised
controlled trial. This aim will draw on the results of Aim1 to tailor the breast cancer Early
Diagnosis intervention by Pace and colleagues focusing on awareness, clinical breast exams
and improving the referral system.
Specific Aim 3: Co-create an implementation package and tailoring implementation
strategies to the Kenyan context to improve intervention-context fit. This aim builds on the
results of Specific Aims 1 and 2 and involves the co-creation of a training package to enhance
the knowledge of Community Health Workers and primary healthcare workers on risk
factors, symptoms of female breast cancer, the importance of seeking timely medical
evaluation for breast concerns and reducing local barriers to accessing breast health care.
Primary healthcare workers will further be trained on the performance of clinical breast
examinations. This aim further involves the collaborative creation and tailoring of
implementation strategies considering the local implementation determinants.
Specific Aim 4: Evaluate the effectiveness of the BreCATH-B program by assessing its
impact on the level of breast cancer awareness, level of utilization of clinical breast
examination, length of patient and primary care intervals and number of referrals. The aim
focuses on evaluating the intervention’s primary and secondary outcomes arising from the
implementation of the intervention highlighted in Specific Aim 3.
Specific Aim 5: Describe the implementation process and degree to which the BreCATH-B
program was successfully implemented, with a focus on its reach, effectiveness, adoption,
implementation, and maintenance (RE-AIM domains), including health equity outcomes.

Specific Aim 6: Conduct an economic evaluation of implementation strategies for the
BreCATH-B program. The aim seeks to evaluate the cost of implementation strategies across
the phases of intervention implementation from a provider’s perspective.