Breast CancerBCEDNCT03919682
Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of Community Health Worker and Nurse Training
A study testing Experimental: Training, Phase 1 and Experimental: Training, Phase 2 in people with Breast Cancer, run by Brigham and Women's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Experimental: Training, Phase 1 and Experimental: Training, Phase 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,203 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2015to 17 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Community health workers or health center nurses affiliated with a designated intervention health center
- Interested in participating
Who cannot join
- Not interested in participating
- Not available for training
About this study
Official title: Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of a Community Health Worker and Health Center Nurse Training Program
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.
- Conditions
- Breast Cancer
- Being tested
- Experimental: Training, Phase 1, Experimental: Training, Phase 2
- Keywords
- early detection, Rwanda
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Training, Phase 1Other
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 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Training, Phase 1 | Experimental | Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in April-May 2015 Receives: Other: Experimental: Training, Phase 1 |
| Training, Phase 2 | Experimental | Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in November-December 2015 Receives: Other: Experimental: Training, Phase 2 |
| Control | No intervention | 6 health centers served as controls and did not receive training during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 6 months
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).
Measured: up to 6 months
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).
Measured: up to 16 months
Secondary outcomes (8)
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.
Measured: 30 months
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.
Measured: 30 months
Breast ultrasounds
Number of patients from intervention health centers requiring ultrasound before versus after the intervention, and compared with patients from control health centers
Measured: 30 months
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.
Measured: 30 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 30 months
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.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start18 Apr 2015
- Primary completion17 Apr 2017
- Study completion17 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation, University of Pennsylvania, Partners in Health, Ministry of Health, Rwanda
- Responsible party
- Principal investigator, Lydia Pace, MD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919682
- Sponsor's protocol ID
- 2014P002688
- Acronym
- BCED
- Status last verified
- Aug 2021
- First submitted
- 12 Apr 2019
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of a Community Health Worker and Health Center Nurse Training Program
- ClinicalTrials.gov ID
- NCT03919682
- Acronym / sponsor ID
- BCED / 2014P002688
- Conditions
- Breast Cancer
- Keywords
- early detection, Rwanda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,203 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation, University of Pennsylvania, Partners in Health, Ministry of Health, Rwanda
- Study start
- 18 Apr 2015 (actual)
- Primary completion
- 17 Apr 2017 (actual)
- Study completion
- 17 Apr 2017 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training, Phase 1 | Experimental | Other: Experimental: Training, Phase 1Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in April-May 2015 |
| Training, Phase 2 | Experimental | Other: Experimental: Training, Phase 2Community health workers and nurses affiliated with 7 health centers received the breast cancer early detection trainings in November-December 2015 |
| Control | No intervention | –6 health centers served as controls and did not receive training during the study period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Community health workers or health center nurses affiliated with a designated intervention health center
- Interested in participating
Key exclusion criteria (2 listed)
- Not interested in participating
- Not available for training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Training, Phase 1Weeklong 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. | Other | Training, Phase 1 |
| Experimental: Training, Phase 2Weeklong 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. | Other | Training, Phase 2 |
Primary outcome
Health center nurse knowledge
Time frame: up 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).
Community health worker knowledge
Time frame: up 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 clinical skills
Time frame: up 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).
8 secondary outcomes
Health center volume
Time frame: 30 months
District hospital referrals
Time frame: 30 months
Breast ultrasounds
Time frame: 30 months
Breast biopsy
Time frame: 30 months
Patient delays
Time frame: 24 months
System delays
Time frame: 24 months
Breast cancer detection rate
Time frame: 30 months
Breast cancer stage
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Training, Phase 1 and Experimental: Training, Phase 2 in people with Breast Cancer, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health center nurse knowledge (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.