Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda

NCT05364138 | Completed

• 1 other identifier: 2021P002943
• Study Type: observational
• Target: 2,357
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer incidence is increasing in low- and middle-income countries (LMICs) and breast cancer mortality is high in these regions largely due to late stage diagnoses. This is true in the low-income East African country of Rwanda, where there are no national protocols in place to guide evaluation and referral of breast symptoms at primary health facilities. This study will use quantitative and qualitative methods to examine implementation of the Women's Cancer Early Detection Program (WCEDP) in order to understand optimal strategies to scale and sustain breast cancer early diagnosis in Rwanda and other limited-resource settings. The WCEDP is an adaptation of a prior intervention in Burera District, which focused on building community awareness of breast symptoms, improving clinicians' clinical breast assessment (CBA) skills, and implementing weekly breast clinics at the primary health care center and hospital levels. The Burera intervention was associated with improvements in health care workers' knowledge and skills, increases in care-seeking and receipt of care by women with breast symptoms, and an increase in early-stage breast cancer diagnoses.

Conditions

Breast Cancer; Benign Breast Disease; Cervix Cancer

Keywords

Rwanda; breast cancer; screening; early detection

Outcome Measures

Primary Outcomes (1)

• Number of patients presenting to health centers for CBA per week (Reach)

  The primary analysis will be interrupted time series (ITS) Poisson regression to compare the number of patients presenting for CBA to health centers each week in the months before and after initiation of the WCEDP

  12 months

Secondary Outcomes (11)

• Age of patients received (Reach)

  18 months

• Proportion of patients receiving CBA who had breast symptoms (Reach)

  18 months

• Proportion of patients evaluated with CBA at health centers who also had cervical cancer screening (Reach)

  18 months

• WCEDP Effectiveness - HCs

  12 months

• WCEDP Effectiveness - DHs

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• 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 individuals 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
• Partners in Health: collaborator
• Rwanda Biomedical Centre: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Partners in Health (Inshuti Mu Buzima)

Butaro, Rwanda

Location

MeSH Terms

Conditions

Breast Neoplasms; Cystic Fibrosis; Uterine Cervical Neoplasms

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; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lydia Pace, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: May 6, 2022
• Study Start: July 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

RW (1)