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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer, Benign Breast Disease

Intervention / Treatment
-----------------
* Other: Early diagnosis program combined with electronic medical record


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening plus EMR<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rwanda, breast cancer, screening, early detection