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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03919682

Recruitment Status Completed

First Posted April 18, 2019

Last update posted April 18, 2019

Study Description

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:Breast Cancer
  • Intervention/Treatment: Other: Experimental: Training, Phase 1
    Other: Experimental: Training, Phase 2
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2015
  • Actual Primary Completion Date: April 2017
  • Actual Study Completion Date: April 2017
Arms and interventions
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.
Outcome Measures
  • 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.
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Brigham and Women's Hospital

Breast Cancer Research Foundation

University of Pennsylvania

Partners in Health

Ministry of Health, Rwanda

More Information
  • Responsible Party: 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Brigham and Women's Hospital: early detection, Rwanda
  • Additional relevant MeSH terms: Breast Neoplasms