Breast CancerNCT05364138
Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda
An observational study of Breast Cancer and Benign Breast Disease, run by Brigham and Women's Hospital at 1 site in Rwanda.
Trial summary
Breast cancer incidence is increasing in low- and middle-income countries (LMICs) and breast cancer mortality is high in these regions largely due to late stage diagnoses. This is true in the low-income East African country of Rwanda, where there are no national protocols in place to guide evaluation and referral of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Benign Breast Disease, Cervix Cancer
- How many people
- 2,357 participants
- Where
- 1 siteRwanda
- Study dates
- 31 Jul 2023to 31 Dec 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population is the population served by the health centers that are implementing the nationally-led breast cancer early detection program.
Who may be able to join
- All individuals who are evaluated for a breast concern or receive breast cancer screening through implementation of the nationally-led early detection programs
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer incidence is increasing in low- and middle-income countries (LMICs) and breast cancer mortality is high in these regions largely due to late stage diagnoses. This is true in the low-income East African country of Rwanda, where there are no national protocols in place to guide evaluation and referral of breast symptoms at primary health facilities.
This study will use quantitative and qualitative methods to examine implementation of the Women's Cancer Early Detection Program (WCEDP) in order to understand optimal strategies to scale and sustain breast cancer early diagnosis in Rwanda and other limited-resource settings. The WCEDP is an adaptation of a prior intervention in Burera District, which focused on building community awareness of breast symptoms, improving clinicians' clinical breast assessment (CBA) skills, and implementing weekly breast clinics at the primary health care center and hospital levels. The Burera intervention was associated with improvements in health care workers' knowledge and skills, increases in care-seeking and receipt of care by women with breast symptoms, and an increase in early-stage breast cancer diagnoses.
Read the detailed description
Despite the Burera trial's promising results it was clear adaptations would be needed for real-world scaleup. The Burera intervention focused on breast health in isolation, hindering scalability in a limited-resource health system. In addition, it benefited from intensive patient tracking, feasible with the study's resources and implementation in a single district. Rwanda Biomedical Centre (RBC) is now scaling up breast cancer early diagnosis using the Burera training program with two key adaptations. First, in an effort to expand reach and increase efficiency, breast cancer early diagnosis services are offered together with cervical cancer screening in a combined initiative, the Women's Cancer Early Detection Program. The WCEDP combines these services through: 1)Combined provider trainings; 2)Community awareness-raising about both cancers; and 3)Weekly district hospital (DH) and HC clinics for women eligible for cervical cancer screening and CBA. RBC's second adaptation, an effort to facilitate patient tracking and linkage to care at scale, is a tablet-based EMR that allows clinicians to share information across facilities, identify missed visits, and document patient phone calls. These adaptations address priorities of the WHO's Global Breast Cancer Initiative: integrating early diagnosis into primary care services and building systems to facilitate referrals. By examining these adaptations in a real-world setting, this research will contribute to global efforts to identify evidence-based implementation strategies to address breast cancer in LMICs.
This study will leverage a longstanding partnership between RBC, Partners In Health (PIH), and Brigham and Women's Hospital (BWH) to pursue the following Specific Aims:
Aim 1. Use the RE-AIM framework to examine implementation and impact of Rwanda's adaptation and scale-up of breast cancer early diagnosis within the WCEDP, in 3 districts with 52 HCs.
1a. Evaluate the WCEDP's reach using interrupted time series analysis to examine its impact on the number of patients receiving CBA at HCs, and engagement of older women and those with breast symptoms.
1b. Examine program effectiveness, adoption and implementation by assessing timely linkage to care, loss-to-follow-up, service delivery, and EMR use.
Aim 2. Use patient and provider interviews, guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, to elicit contextual factors related to successes and challenges of scaleup, including the WCEDP's fit and acceptability for communities, clinicians, and facilities.
- Conditions
- Breast Cancer, Benign Breast Disease, Cervix Cancer
- Keywords
- Rwanda, breast cancer, screening, early detection
- Medical subject headings
- Breast Neoplasms, Cystic Fibrosis, Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients presenting to health centers for CBA per week (Reach)
The primary analysis will be interrupted time series (ITS) Poisson regression to compare the number of patients presenting for CBA to health centers each week in the months before and after initiation of the WCEDP
Measured: 12 months
Secondary outcomes (11)
Age of patients received (Reach)
The investigators will examine the median age of individuals presenting before and after WCEDP
Measured: 18 months
Proportion of patients receiving CBA who had breast symptoms (Reach)
Investigators will examine the proportion of patients evaluated at health centers with CBA who had symptoms
Measured: 18 months
Proportion of patients evaluated with CBA at health centers who also had cervical cancer screening (Reach)
Proportion of patients evaluated with CBA at health centers who also had cervical cancer screening (Reach)
Measured: 18 months
WCEDP Effectiveness - HCs
Number and percentage of women seen at health centers for CBA who are referred to district hospitals (and seen within 1 month of DH visit)
Measured: 12 months
WCEDP Effectiveness - DHs
Number and percentage of women seen at district hospitals for CBA who are referred to referral facilities (and seen within 1 month of DH visit)
Measured: 12 months
WCEDP Adoption - CHWs
Number and percentage of community health workers (CHWs) trained
Measured: 12 months
WCEDP Adoption - Clinicians
Number and percentage of clinicians trained in the program and in electronic medical record
Measured: 12 months
WCEDP Implementation - Clinics
Number and percentage of weeks that clinics are held at each health center and district hospital (and the average percentage per district)
Measured: 6 and 12 months
WCEDP Implementation - CHWs
Number of days/ month that CHWs hold community awareness events or do home visits (and average percentage per district)
Measured: 6 and 12 months
WCEDP Implementation - electronic medical record
Proportion of weeks in which electronic medical record missed-visit reports are run in each district hospital
Measured: 6 and 12 months
WCEDP Implementation - Phone calls
Of patients who have missed district hospital visits, percentage with phone call documented in the electronic medical record
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start31 Jul 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Partners in Health, Rwanda Biomedical Centre, Johns Hopkins University
- Responsible party
- Principal investigator, Lydia Pace, MD, MPH, Brigham and Women's Hospital
- Investigators
- Lydia Pace, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364138
- Sponsor's protocol ID
- 2021P002943
- Status last verified
- Feb 2025
- First submitted
- 29 Mar 2022
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda
- ClinicalTrials.gov ID
- NCT05364138
- Acronym / sponsor ID
- 2021P002943
- Conditions
- Breast Cancer, Benign Breast Disease, Cervix Cancer
- Keywords
- Rwanda, breast cancer, screening, early detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,357 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Partners in Health, Rwanda Biomedical Centre, Johns Hopkins University
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 May 2022 (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.
Breast cancer incidence is increasing in low- and middle-income countries (LMICs) and breast cancer mortality is high in these regions largely due to late stage diagnoses. This is true in the low-income East African country of Rwanda, where there are no national protocols in place to guide evaluation and referral of breast symptoms at primary health facilities.
This study will use quantitative and qualitative methods to examine implementation of the Women's Cancer Early Detection Program (WCEDP) in order to understand optimal strategies to scale and sustain breast cancer early diagnosis in Rwanda and other limited-resource settings. The WCEDP is an adaptation of a prior intervention in Burera District, which focused on building community awareness of breast symptoms, improving clinicians' clinical breast assessment (CBA) skills, and implementing weekly breast clinics at the primary health care center and hospital levels. The Burera intervention was associated with improvements in health care workers' knowledge and skills, increases in care-seeking and receipt of care by women with breast symptoms, and an increase in early-stage breast cancer diagnoses.
Detailed description
Despite the Burera trial's promising results it was clear adaptations would be needed for real-world scaleup. The Burera intervention focused on breast health in isolation, hindering scalability in a limited-resource health system. In addition, it benefited from intensive patient tracking, feasible with the study's resources and implementation in a single district. Rwanda Biomedical Centre (RBC) is now scaling up breast cancer early diagnosis using the Burera training program with two key adaptations. First, in an effort to expand reach and increase efficiency, breast cancer early diagnosis services are offered together with cervical cancer screening in a combined initiative, the Women's Cancer Early Detection Program. The WCEDP combines these services through: 1)Combined provider trainings; 2)Community awareness-raising about both cancers; and 3)Weekly district hospital (DH) and HC clinics for women eligible for cervical cancer screening and CBA. RBC's second adaptation, an effort to facilitate patient tracking and linkage to care at scale, is a tablet-based EMR that allows clinicians to share information across facilities, identify missed visits, and document patient phone calls. These adaptations address priorities of the WHO's Global Breast Cancer Initiative: integrating early diagnosis into primary care services and building systems to facilitate referrals. By examining these adaptations in a real-world setting, this research will contribute to global efforts to identify evidence-based implementation strategies to address breast cancer in LMICs.
This study will leverage a longstanding partnership between RBC, Partners In Health (PIH), and Brigham and Women's Hospital (BWH) to pursue the following Specific Aims:
Aim 1. Use the RE-AIM framework to examine implementation and impact of Rwanda's adaptation and scale-up of breast cancer early diagnosis within the WCEDP, in 3 districts with 52 HCs.
1a. Evaluate the WCEDP's reach using interrupted time series analysis to examine its impact on the number of patients receiving CBA at HCs, and engagement of older women and those with breast symptoms.
1b. Examine program effectiveness, adoption and implementation by assessing timely linkage to care, loss-to-follow-up, service delivery, and EMR use.
Aim 2. Use patient and provider interviews, guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, to elicit contextual factors related to successes and challenges of scaleup, including the WCEDP's fit and acceptability for communities, clinicians, and facilities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is the population served by the health centers that are implementing the nationally-led breast cancer early detection program.
Key inclusion criteria (1 listed)
- All individuals who are evaluated for a breast concern or receive breast cancer screening through implementation of the nationally-led early detection programs
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients presenting to health centers for CBA per week (Reach)
Time frame: 12 months
The primary analysis will be interrupted time series (ITS) Poisson regression to compare the number of patients presenting for CBA to health centers each week in the months before and after initiation of the WCEDP
11 secondary outcomes
Age of patients received (Reach)
Time frame: 18 months
Proportion of patients receiving CBA who had breast symptoms (Reach)
Time frame: 18 months
Proportion of patients evaluated with CBA at health centers who also had cervical cancer screening (Reach)
Time frame: 18 months
WCEDP Effectiveness - HCs
Time frame: 12 months
WCEDP Effectiveness - DHs
Time frame: 12 months
WCEDP Adoption - CHWs
Time frame: 12 months
WCEDP Adoption - Clinicians
Time frame: 12 months
WCEDP Implementation - Clinics
Time frame: 6 and 12 months
WCEDP Implementation - CHWs
Time frame: 6 and 12 months
WCEDP Implementation - electronic medical record
Time frame: 6 and 12 months
WCEDP Implementation - Phone calls
Time frame: 6 and 12 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 6 Feb 2025.
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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.
Lydia Pace, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Benign Breast Disease, run by Brigham and Women's Hospital at 1 site in Rwanda.
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 1 inclusion and 1 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of patients presenting to health centers for CBA per week (Reach) (time frame: 12 months). 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 6 Feb 2025.