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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04258085
Enrollment
17379
Registered
2020-02-06
Start date
2020-07-01
Completion date
2022-03-25
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Breast Disease, Breast Cancer

Keywords

Rwanda, breast cancer, screening, early detection

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.

Interventions

OTHEREarly 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

Sponsors

Rwanda Biomedical Centre
CollaboratorOTHER
Partners in Health
CollaboratorOTHER
Breast Cancer Research Foundation
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cancer detection rate2 yearsProportion 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-upone yearRates 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
Patient volume and services receivedtwo yearsNumber of patients presenting at the health centers, district hospital and referral hospitals

Secondary

MeasureTime frameDescription
Breast cancer stage2 yearsAmong women diagnosed with breast cancer, distribution of cancer stage among women who participated in the WCEDP.
Patients' costs6 monthsout-of-pocket costs borne by patients while undergoing evaluation for an abnormal clinical breast exam

Countries

Rwanda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026