Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Cervix Cancer; Benign Breast Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 3096

Contacts and Locations

• Study Contact: Name: Lydia Pace, MD, MPH; Phone Number: 4154657223; Email: lpace@bwh.harvard.edu

Study Locations

• Rwanda
  • Butaro, Rwanda
    • Recruiting
    • Partners in Health (Inshuti Mu Buzima)
    • Contact: Vincent Cubaka, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients presenting to health centers for CBA per week (Reach)	The primary analysis will be interrupted time series (ITS) Poisson regression to compare the number of patients presenting for CBA to health centers each week in the months before and after initiation of the WCEDP	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of patients received (Reach)	The investigators will examine the median age of individuals presenting before and after WCEDP	18 months
Proportion of patients receiving CBA who had breast symptoms (Reach)	Investigators will examine the proportion of patients evaluated at health centers with CBA who had symptoms	18 months
Proportion of patients evaluated with CBA at health centers who also had cervical cancer screening (Reach)	Proportion of patients evaluated with CBA at health centers who also had cervical cancer screening (Reach)	18 months
WCEDP Effectiveness - HCs	Number and percentage of women seen at health centers for CBA who are referred to district hospitals (and seen within 1 month of DH visit)	12 months
WCEDP Effectiveness - DHs	Number and percentage of women seen at district hospitals for CBA who are referred to referral facilities (and seen within 1 month of DH visit)	12 months
WCEDP Adoption - CHWs	Number and percentage of community health workers (CHWs) trained	12 months
WCEDP Adoption - Clinicians	Number and percentage of clinicians trained in the program and in electronic medical record	12 months
WCEDP Implementation - Clinics	Number and percentage of weeks that clinics are held at each health center and district hospital (and the average percentage per district)	6 and 12 months
WCEDP Implementation - CHWs	Number of days/ month that CHWs hold community awareness events or do home visits (and average percentage per district)	6 and 12 months
WCEDP Implementation - electronic medical record	Proportion of weeks in which electronic medical record missed-visit reports are run in each district hospital	6 and 12 months
WCEDP Implementation - Phone calls	Of patients who have missed district hospital visits, percentage with phone call documented in the electronic medical record	6 and 12 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Johns Hopkins University; Partners in Health; Rwanda Biomedical Centre
• Investigators: Principal Investigator: Lydia Pace, MD, MPH, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; early detection; screening; Rwanda
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Breast Neoplasms; Breast Diseases; Fibrocystic Breast Disease
• Other Study ID Numbers: 2021P002943

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No