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

NCT04258085 | Completed

• 1 other identifier: 2014P002688a
• Study Type: observational
• Target: 17,379
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Benign Breast Disease

Keywords

Rwanda; breast cancer; screening; early detection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Breast cancer stage

  2 years

• Patients' costs

  6 months

Study Arms (1)

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

Interventions

Early diagnosis program combined with electronic medical record 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

Screening plus EMR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Rwanda Biomedical Centre: collaborator
• Partners in Health: collaborator
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Rwanda Biomedical Centre

Kigali, Rwanda

Location

MeSH Terms

Conditions

Breast Neoplasms; Cystic Fibrosis

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lydia Pace

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 25, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

RW (1)