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

Completed

• Conditions: Benign Breast Disease; Breast Cancer
• Interventions: Other: Early diagnosis program combined with electronic medical record

• Registration Number: NCT04258085
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Study Start: 2020-07-01
• Primary Completion: 2021-12-31
• Status Verified: 2022-03
• Study Completion: 2022-03-25
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17379

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening plus EMR	Early diagnosis program combined with electronic medical record	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).

Primary Outcome Measures

Name	Time	Method
Patient volume and services received	two years	Number of patients presenting at the health centers, district hospital and referral hospitals
Cancer detection rate	2 years	Proportion of patients presenting to health centers who are ultimately diagnosed with cancer; proportion of patients who receive biopsy who are ultimately diagnosed with cancer; proportion of individuals diagnosed with cancer who initially presented with versus without breast symptoms
Loss to follow-up	one year	Rates of loss-to-follow up before and after implementation of electronic medical record in districts utilizing breast cancer screening approach; and loss to follow up in districts implementing early diagnosis approach and EMR

Secondary Outcome Measures

Name	Time	Method
Breast cancer stage	2 years	Among women diagnosed with breast cancer, distribution of cancer stage among women who participated in the WCEDP.
Patients' costs	6 months	out-of-pocket costs borne by patients while undergoing evaluation for an abnormal clinical breast exam

Trial Locations

Locations (1)

Rwanda Biomedical Centre; 🇷🇼 Kigali, Rwanda