Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System

NCT ID: NCT04258085

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17379 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-03-25

Brief Summary

This observational study evaluates scale-up of a breast cancer early detection program in Rwanda that was initially piloted in a single district. Specifically investigators will examine patient volume, service delivery, loss-to-follow-up rates, and cancer detection rates noted following implementation of scale-up to 3 additional districts. For scaleup, breast cancer screening with CBE was added to a cervical cancer screening initiative, in a combined Women's Cancer Early Detection Program (WCEDP).

Detailed Description

Investigators previously conducted a cluster randomized controlled trial of a clinician training program to facilitate prompt evaluation of women with breast symptoms in one rural district of Rwanda. Subsequently, Rwanda Biomedical Centre (RBC) has scaled up the curriculum in 3 districts, adapting the program to integrate CBE screening into a cervical cancer screening initiative. In this study, we will evaluate implementation of this combined screening initiative. Investigators will assess patient volume, services, diagnoses, and loss to follow up.

Conditions

Breast Cancer; Benign Breast Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Screening plus EMR

Individuals in this group are those residing in districts where health facilities have implemented a breast cancer screening program integrated with cervical cancer screening, the Women's Cancer Early Detection Program (WCEDP).

Early diagnosis program combined with electronic medical record

Intervention Type: OTHER

Implementation of early diagnosis approach targeting symptomatic women, combined with use of electronic medical record to facilitate documentation, patient tracking across levels of the health care system, and patient contact

Interventions

Early diagnosis program combined with electronic medical record

Implementation of early diagnosis approach targeting symptomatic women, combined with use of electronic medical record to facilitate documentation, patient tracking across levels of the health care system, and patient contact

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All women and men who are evaluated for a breast concern or receive breast cancer screening through implementation of the nationally-led early detection programs

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rwanda Biomedical Centre

OTHER

Sponsor Role: collaborator

Partners in Health

OTHER

Sponsor Role: collaborator

Breast Cancer Research Foundation

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lydia Pace, MD, MPH

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lydia Pace

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Rwanda Biomedical Centre

Kigali, , Rwanda

Countries

Rwanda

Other Identifiers

2014P002688a

Identifier Type: -

Identifier Source: org_study_id