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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental: Training, Phase 1
Experimental: Training, Phase 2
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring early detection, Rwanda

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Community health workers or health center nurses affiliated with a designated intervention health center
  • Interested in participating

Exclusion Criteria

  • Not interested in participating
  • Not available for training

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Training, Phase 1

    Training, Phase 2

    Control

    Arm Description

    Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in April-May 2015

    Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in November-December 2015

    6 health centers served as controls and did not receive training during the study period

    Outcomes

    Primary Outcome Measures

    Health center nurse knowledge
    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).
    Community health worker knowledge
    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 clinical skills
    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

    Health center volume
    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 referrals
    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 ultrasounds
    Number of patients from intervention health centers requiring ultrasound before versus after the intervention, and compared with patients from control health centers
    Breast biopsy
    Number of patients from intervention health centers requiring breast biopsy before versus after the intervention, and compared with patients from control health centers.
    Patient delays
    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.
    System delays
    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.
    Breast cancer detection rate
    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 stage
    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.

    Full Information

    First Posted
    April 12, 2019
    Last Updated
    August 23, 2021
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    Breast Cancer Research Foundation, University of Pennsylvania, Partners in Health, Ministry of Health, Rwanda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03919682
    Brief Title
    Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of Community Health Worker and Nurse Training
    Acronym
    BCED
    Official Title
    Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of a Community Health Worker and Health Center Nurse Training Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 18, 2015 (Actual)
    Primary Completion Date
    April 17, 2017 (Actual)
    Study Completion Date
    April 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital
    Collaborators
    Breast Cancer Research Foundation, University of Pennsylvania, Partners in Health, Ministry of Health, Rwanda

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    early detection, Rwanda

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1203 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Training, Phase 1
    Arm Type
    Experimental
    Arm Description
    Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in April-May 2015
    Arm Title
    Training, Phase 2
    Arm Type
    Experimental
    Arm Description
    Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in November-December 2015
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    6 health centers served as controls and did not receive training during the study period
    Intervention Type
    Other
    Intervention Name(s)
    Experimental: Training, Phase 1
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Experimental: Training, Phase 2
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Health center nurse knowledge
    Description
    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).
    Time Frame
    up to 6 months
    Title
    Community health worker knowledge
    Description
    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).
    Time Frame
    up to 6 months
    Title
    Health center nurse clinical skills
    Description
    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).
    Time Frame
    up to 16 months
    Secondary Outcome Measure Information:
    Title
    Health center volume
    Description
    Number of patients per month with breast concerns presenting at health centers before versus after the intervention, and compared with control health centers.
    Time Frame
    30 months
    Title
    District hospital referrals
    Description
    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.
    Time Frame
    30 months
    Title
    Breast ultrasounds
    Description
    Number of patients from intervention health centers requiring ultrasound before versus after the intervention, and compared with patients from control health centers
    Time Frame
    30 months
    Title
    Breast biopsy
    Description
    Number of patients from intervention health centers requiring breast biopsy before versus after the intervention, and compared with patients from control health centers.
    Time Frame
    30 months
    Title
    Patient delays
    Description
    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.
    Time Frame
    24 months
    Title
    System delays
    Description
    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.
    Time Frame
    24 months
    Title
    Breast cancer detection rate
    Description
    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.
    Time Frame
    30 months
    Title
    Breast cancer stage
    Description
    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.
    Time Frame
    30 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Community health workers or health center nurses affiliated with a designated intervention health center Interested in participating Exclusion Criteria Not interested in participating Not available for training

    12. IPD Sharing Statement

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

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