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

August 23, 2021 updated by: Lydia Pace, MD, MPH, Brigham and Women's Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1203

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
up to 6 months
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).
up to 6 months
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).
up to 16 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
30 months
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.
30 months
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
30 months
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.
30 months
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.
24 months
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.
24 months
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.
30 months
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.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania
Breast Cancer Research Foundation
Ministry of Health, Rwanda
Partners in Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014P002688

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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