Clinical trial NCT05364138: Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda
Official title: Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Benign Breast Disease
Cervix Cancer
Keywords: Rwanda
breast cancer
screening
early detection
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Partners in Health
name: Rwanda Biomedical Centre
name: Johns Hopkins University
First posted: 2022-05-06
Enrollment: 2357
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is the population served by the health centers that are implementing the nationally-led breast cancer early detection program.

Brief summary: Breast cancer incidence is increasing in low- and middle-income countries (LMICs) and breast cancer mortality is high in these regions largely due to late stage diagnoses. This is true in the low-income East African country of Rwanda, where there are no national protocols in place to guide evaluation and referral of breast symptoms at primary health facilities.

This study will use quantitative and qualitative methods to examine implementation of the Women's Cancer Early Detection Program (WCEDP) in order to understand optimal strategies to scale and sustain breast cancer early diagnosis in Rwanda and other limited-resource settings. The WCEDP is an adaptation of a prior intervention in Burera District, which focused on building community awareness of breast symptoms, improving clinicians' clinical breast assessment (CBA) skills, and implementing weekly breast clinics at the primary health care center and hospital levels. The Burera intervention was associated with improvements in health care workers' knowledge and skills, increases in care-seeking and receipt of care by women with breast symptoms, and an increase in early-stage breast cancer diagnoses.

Detailed description: Despite the Burera trial's promising results it was clear adaptations would be needed for real-world scaleup. The Burera intervention focused on breast health in isolation, hindering scalability in a limited-resource health system. In addition, it benefited from intensive patient tracking, feasible with the study's resources and implementation in a single district. Rwanda Biomedical Centre (RBC) is now scaling up breast cancer early diagnosis using the Burera training program with two key adaptations. First, in an effort to expand reach and increase efficiency, breast cancer early diagnosis services are offered together with cervical cancer screening in a combined initiative, the Women's Cancer Early Detection Program. The WCEDP combines these services through: 1)Combined provider trainings; 2)Community awareness-raising about both cancers; and 3)Weekly district hospital (DH) and HC clinics for women eligible for cervical cancer screening and CBA. RBC's second adaptation, an effort to facilitate patient tracking and linkage to care at scale, is a tablet-based EMR that allows clinicians to share information across facilities, identify missed visits, and document patient phone calls. These adaptations address priorities of the WHO's Global Breast Cancer Initiative: integrating early diagnosis into primary care services and building systems to facilitate referrals. By examining these adaptations in a real-world setting, this research will contribute to global efforts to identify evidence-based implementation strategies to address breast cancer in LMICs.

This study will leverage a longstanding partnership between RBC, Partners In Health (PIH), and Brigham and Women's Hospital (BWH) to pursue the following Specific Aims:

Aim 1. Use the RE-AIM framework to examine implementation and impact of Rwanda's adaptation and scale-up of breast cancer early diagnosis within the WCEDP, in 3 districts with 52 HCs.

1a. Evaluate the WCEDP's reach using interrupted time series analysis to examine its impact on the number of patients receiving CBA at HCs, and engagement of older women and those with breast symptoms.

1b. Examine program effectiveness, adoption and implementation by assessing timely linkage to care, loss-to-follow-up, service delivery, and EMR use.

Aim 2. Use patient and provider interviews, guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, to elicit contextual factors related to successes and challenges of scaleup, including the WCEDP's fit and acceptability for communities, clinicians, and facilities.

Eligibility criteria: Inclusion Criteria:

* All individuals who are evaluated for a breast concern or receive breast cancer screening through implementation of the nationally-led early detection programs

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of patients presenting to health centers for CBA per week (Reach)
timeFrame: 12 months
Secondary outcomes:
measure: Age of patients received (Reach)
timeFrame: 18 months
measure: Proportion of patients receiving CBA who had breast symptoms (Reach)
timeFrame: 18 months
measure: Proportion of patients evaluated with CBA at health centers who also had cervical cancer screening (Reach)
timeFrame: 18 months
measure: WCEDP Effectiveness - HCs
timeFrame: 12 months
measure: WCEDP Effectiveness - DHs
timeFrame: 12 months
measure: WCEDP Adoption - CHWs
timeFrame: 12 months
measure: WCEDP Adoption - Clinicians
timeFrame: 12 months
measure: WCEDP Implementation - Clinics
timeFrame: 6 and 12 months
measure: WCEDP Implementation - CHWs
timeFrame: 6 and 12 months
measure: WCEDP Implementation - electronic medical record
timeFrame: 6 and 12 months
measure: WCEDP Implementation - Phone calls
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Butaro
country: Rwanda
facility: Partners in Health (Inshuti Mu Buzima)
Study officials:
affiliation: Brigham and Women's Hospital
name: Lydia Pace, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: