Clinical trialObsCompleted
Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System
- Outcome
- Finished, no results posted
- Phase
- Obs
- Status
- Completed
- Study type
- Observational
- Start
- 1 July 2020
- Expected end
- 25 March 2022
- Enrollment
- 17,379 participants
- Sites
- 1
- Primary outcomes
- Cancer detection rate; Loss to follow-up; Patient volume and services received
- Sponsor
- Other
- Results posted
- No
- Last update
- 7 April 2022
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
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
Arm public domain (ClinicalTrials.gov)
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).
Primary outcome public domain (ClinicalTrials.gov)
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 Time frame: 2 years.
Primary outcome public domain (ClinicalTrials.gov)
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 Time frame: one year.
Primary outcome public domain (ClinicalTrials.gov)
Patient volume and services received. Number of patients presenting at the health centers, district hospital and referral hospitals Time frame: two years.
Secondary outcome public domain (ClinicalTrials.gov)
Breast cancer stage. Time frame: 2 years.
Secondary outcome public domain (ClinicalTrials.gov)
Patients' costs. Time frame: 6 months.
Eligibility public domain (ClinicalTrials.gov)
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
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 17379 participants (actual).