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

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Benign Breast Disease
• Intervention / Treatment: Other: Early diagnosis program combined with electronic medical record

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 Type: Observational
• Enrollment (Actual): 17379

Contacts and Locations

Study Locations

• Rwanda
  • Kigali, Rwanda
    • Rwanda Biomedical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer detection rate	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	2 years
Loss to follow-up	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	one year
Patient volume and services received	Number of patients presenting at the health centers, district hospital and referral hospitals	two years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Breast Cancer Research Foundation; Partners in Health; Rwanda Biomedical Centre
• Investigators: Principal Investigator: Lydia Pace, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): March 25, 2022

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: breast cancer; early detection; screening; Rwanda
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Neoplasms; Breast Diseases; Fibrocystic Breast Disease
• Other Study ID Numbers: 2014P002688a

Drug and device information, study documents

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