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

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ClinicalTrials.gov Identifier: NCT03919682
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Breast Cancer Research Foundation
University of Pennsylvania
Partners in Health
Ministry of Health, Rwanda
Information provided by (Responsible Party):
Lydia Pace, MD, MPH, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Experimental: Training, Phase 1 Other: Experimental: Training, Phase 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of a Community Health Worker and Health Center Nurse Training Program
Actual Study Start Date : April 18, 2015
Actual Primary Completion Date : April 17, 2017
Actual Study Completion Date : April 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Training, Phase 1
Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in April-May 2015
Other: Experimental: Training, Phase 1
Weeklong training in signs, symptoms and treatability of breast cancer, performance of clinical breast exam, and structured algorithms for management of breast complaints followed by regular mentorship for health center nurses. CHWs received a one-day training in breast awareness and how to educate communities about breast health.

Experimental: Training, Phase 2
Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in November-December 2015
Other: Experimental: Training, Phase 2
Weeklong training in signs, symptoms and treatability of breast cancer, performance of clinical breast exam, and structured algorithms for management of breast complaints followed by regular mentorship for health center nurses. CHWs received a one-day training in breast awareness and how to educate communities about breast health.

No Intervention: Control
6 health centers served as controls and did not receive training during the study period



Primary Outcome Measures :
  1. Health center nurse knowledge [ Time Frame: up to 6 months ]
    Scores on tests of knowledge immediately after and 3-6 months after the trainings, compared with before the trainings. 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.

  2. Community health worker knowledge [ Time Frame: up to 6 months ]
    Scores on tests of knowledge immediately after and 3-6 months after the trainings, compared with before the trainings. 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.

  3. Health center nurse clinical skills [ Time Frame: up to 12 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.


Secondary Outcome Measures :
  1. Health center volume [ Time Frame: 30 months ]
    Number of patients per month with breast concerns presenting at health centers before versus after the intervention, and compared with control health centers.

  2. District hospital referrals [ Time Frame: 30 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.

  3. Breast ultrasounds [ Time Frame: 30 months ]
    Number of patients from intervention health centers requiring ultrasound before versus after the intervention, and compared with patients from control health centers

  4. Breast biopsy [ Time Frame: 30 months ]
    Number of patients from intervention health centers requiring breast biopsy before versus after the intervention, and compared with patients from control health centers.

  5. Patient delays [ Time Frame: 24 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.

  6. System delays [ Time Frame: 24 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.

  7. Breast cancer detection rate [ Time Frame: 30 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.

  8. Breast cancer stage [ Time Frame: 30 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Community health workers or health center nurses affiliated with a designated intervention health center and interested in participating.

Exclusion Criteria: Not interested in participating or not available for training.


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Responsible Party: Lydia Pace, MD, MPH, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03919682     History of Changes
Other Study ID Numbers: 2014P002688
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lydia Pace, MD, MPH, Brigham and Women's Hospital:
early detection, Rwanda
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases