Promoting Earlier Detection Of Breast Cancer In Rwanda: Scaleup In The National Health Care System

Study Overview

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).

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.

Breast Cancer
Benign Breast Disease

OTHER: Early diagnosis program combined with electronic medical record

2014P002688a

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-02-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-03-29
First Submitted that Met QC Criteria 2020-02-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-04-07
First Posted (ACTUAL) 2020-02-06	Results First Posted N/A	Last Verified 2022-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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

Participant Group/Arm

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

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

None

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Rwanda Biomedical Centre
Partners in Health
Breast Cancer Research Foundation

Investigators

PRINCIPAL_INVESTIGATOR: Lydia Pace, Brigham and Women's Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record