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
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring early detection, Rwanda
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
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
NCT ID
NCT03919682
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
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
Learn more about this trial
Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of Community Health Worker and Nurse Training
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