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Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of Community Health Worker and Nurse Training

Not Applicable
Completed
Conditions
Breast Cancer
Registration Number
NCT03919682
Lead Sponsor
Brigham and Women's Hospital
Brief Summary

This project proposes a pilot intervention in Burera District to train rural Rwandan community health workers (CHWs) in breast awareness, and to train primary care nurses at rural health centers in the assessment and management of breast complaints, with a focus on when patients must be urgently referred for more advanced evaluation. The project will randomize health centers to receive the intervention and will evaluate the impact of these trainings on nurse and CHW knowledge and skills. In order to help Rwanda prepare for national early detection efforts, the investigators will also assess the impact of these trainings on patient volume at the health center level, and visits and further diagnostic testing at the district hospital level. The investigators will also examine the impact on the length of diagnostic delays experienced by patients with a breast problem. Among those patients diagnosed with breast cancer, the investigators will also assess their stage at diagnosis.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1203
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Community health worker knowledgeup to 6 months

CHWs' knowledge will be assessed through written tests administered immediately before and immediately after trainings, and delayed post-tests administered 3 to 6 months after training. The investigators will use an adapted instrument that incorporates the Breast Cancer Knowledge Test and other surveys to assess clinician knowledge about breast cancer risk, signs and symptoms, and treatability. Questions were developed through review of existing instruments used in the United States, Mexico, the United Kingdom, and Nigeria, and expert input, feedback from clinical colleagues in Rwanda, and pilot testing with Rwandan hospital-based nurses. We will assess each CHW's overall test score as the total percentage of questions correct and assess scores within specific knowledge domains. The more questions answered correctly and the higher the score, the better the outcome (the score represents the percent of questions answered correctly).

Health center nurse knowledgeup to 6 months

Nurses' knowledge will be assessed through written tests administered immediately before and immediately after trainings, and delayed post-tests administered 3 to 6 months after training. The investigators will use an adapted instrument that incorporates the Breast Cancer Knowledge Test and other surveys to assess clinician knowledge about breast cancer risk, signs and symptoms, and treatability. Questions were developed through review of existing instruments used in the United States, Mexico, the United Kingdom, and Nigeria, and expert input, feedback from clinical colleagues in Rwanda, and pilot testing with Rwandan hospital-based nurses. We will assess each nurse's overall test score as the total percentage of questions correct and assess scores within specific knowledge domains. The more questions answered correctly and the higher the score, the better the outcome (the score represents the percent of questions answered correctly).

Health center nurse clinical skillsup to 16 months

Nurses' performance scores on clinical breast exam checklists that assess completion of the steps required for high-quality clinical breast exam and are based on other published checklists adapted to the rural Rwandan setting. CBE materials were based on CBE guidelines and published and unpublished curricula adapted to our setting. During her regular health center visits, the breast health mentor will assess nurses' clinical skills in their clinics by using a checklist that includes the same questions as the pre- and post-test assessment form. When possible, the mentor will assess individual nurses by using the same checklist two or more times during a given clinical session, including one at the beginning of a session. We will analyze checklists completed between May 2015 and September 2016. The more actions performed correctly and the higher the score, the better the outcome (the score represents the percent of actions performed correctly).

Secondary Outcome Measures
NameTimeMethod
System delays24 months

Among patients referred from intervention versus control health centers to the hospital for breast concerns, length of time experienced between first presentation at a health center and first presentation at the hospital.

Health center volume30 months

Number of patients per month with breast concerns presenting at health centers before versus after the intervention, and compared with control health centers.

District hospital referrals30 months

Number of patients from intervention health centers requiring referral to the district hospital before versus after the intervention, and compared with patients from control health centers.

Breast ultrasounds30 months

Number of patients from intervention health centers requiring ultrasound before versus after the intervention, and compared with patients from control health centers

Breast biopsy30 months

Number of patients from intervention health centers requiring breast biopsy before versus after the intervention, and compared with patients from control health centers.

Patient delays24 months

Among patients referred from intervention versus control health centers to the hospital for breast concerns, length of time experienced between onset of symptoms and first presentation to a health center.

Breast cancer detection rate30 months

Among patients referred to the hospital from intervention health centers, proportion diagnosed with breast cancer compared to the proportion among those referred from control health centers, and the proportion from intervention health centers before the trainings.

Breast cancer stage30 months

Among patients diagnosed with breast cancer from intervention health centers, the AJCC versus 7 clinical breast cancer stage documented in hospital medical records. The investigators will compare the proportion of patients presenting with Stage I or II stage disease to the proportion with stage I or II disease among those referred from control health centers, and those from intervention health centers before the trainings.

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