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Completed

NCT Number: NCT04258085

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

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).

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Rwanda Biomedical Centre

Kigali, Rwanda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Cancer detection rate

    Time frame: 2 years

    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. Loss to follow-up

    Time frame: one year

    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

  3. Patient volume and services received

    Time frame: two years

    Number of patients presenting at the health centers, district hospital and referral hospitals

Secondary outcomes

  1. Breast cancer stage

    Time frame: 2 years

    Among women diagnosed with breast cancer, distribution of cancer stage among women who participated in the WCEDP.

  2. Patients' costs

    Time frame: 6 months

    out-of-pocket costs borne by patients while undergoing evaluation for an abnormal clinical breast exam

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Breast Cancer Research Foundation
  • Partners in Health
  • Rwanda Biomedical Centre

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 6, 2020
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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