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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04258085
• Other study ID #: 2014P002688a
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: March 25, 2022

Study information

• Verified date: March 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17379
• Est. completion date: March 25, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Breast Disease
• Breast Cancer
• Breast Diseases
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Rwanda	Rwanda Biomedical Centre	Kigali

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Breast Cancer Research Foundation, Partners in Health, Rwanda Biomedical Centre

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Patient volume and services received	Number of patients presenting at the health centers, district hospital and referral hospitals	two years
Secondary	Breast cancer stage	Among women diagnosed with breast cancer, distribution of cancer stage among women who participated in the WCEDP.	2 years
Secondary	Patients' costs	out-of-pocket costs borne by patients while undergoing evaluation for an abnormal clinical breast exam	6 months