Breast CancerNCT04258085
Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System
An observational study of Breast Cancer and Benign Breast Disease, run by Brigham and Women's Hospital at 1 site in Rwanda.
Trial summary
This observational study evaluates scale-up of a breast cancer early detection program in Rwanda that was initially piloted in a single district. Specifically investigators will examine patient volume, service delivery, loss-to-follow-up rates, and cancer detection rates noted following implementation of scale-up to 3… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Benign Breast Disease
- What is being tested?
- Early diagnosis program combined with electronic medical record
- How many people
- 17,379 participants
- Where
- 1 siteRwanda
- Study dates
- 1 Jul 2020to 25 Mar 2022
- 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
- No healthy volunteers
- 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 women and men 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
This observational study evaluates scale-up of a breast cancer early detection program in Rwanda that was initially piloted in a single district. Specifically investigators will examine patient volume, service delivery, loss-to-follow-up rates, and cancer detection rates noted following implementation of scale-up to 3 additional districts. For scaleup, breast cancer screening with CBE was added to a cervical cancer screening initiative, in a combined Women's Cancer Early Detection Program (WCEDP).
Read the detailed description
Investigators previously conducted a cluster randomized controlled trial of a clinician training program to facilitate prompt evaluation of women with breast symptoms in one rural district of Rwanda. Subsequently, Rwanda Biomedical Centre (RBC) has scaled up the curriculum in 3 districts, adapting the program to integrate CBE screening into a cervical cancer screening initiative. In this study, we will evaluate implementation of this combined screening initiative. Investigators will assess patient volume, services, diagnoses, and loss to follow up.
- Conditions
- Breast Cancer, Benign Breast Disease
- Being tested
- Early diagnosis program combined with electronic medical record
- Keywords
- Rwanda, breast cancer, screening, early detection
- Medical subject headings
- Breast Neoplasms, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early diagnosis program combined with electronic medical recordOther
Implementation of early diagnosis approach targeting symptomatic women, combined with use of electronic medical record to facilitate documentation, patient tracking across levels of the health care system, and patient contact
| Study group | Role | What they receive |
|---|---|---|
| Screening plus EMR | Individuals in this group are those residing in districts where health facilities have implemented a breast cancer screening program integrated with cervical cancer screening, the Women's Cancer Early Detection Program (WCEDP). Receives: Other: Early diagnosis program combined with electronic medical record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer detection rate
Proportion of patients presenting to health centers who are ultimately diagnosed with cancer; proportion of patients who receive biopsy who are ultimately diagnosed with cancer; proportion of individuals diagnosed with cancer who initially presented with versus without breast symptoms
Measured: 2 years
Loss to follow-up
Rates of loss-to-follow up before and after implementation of electronic medical record in districts utilizing breast cancer screening approach; and loss to follow up in districts implementing early diagnosis approach and EMR
Measured: one year
Patient volume and services received
Number of patients presenting at the health centers, district hospital and referral hospitals
Measured: two years
Secondary outcomes (2)
Breast cancer stage
Among women diagnosed with breast cancer, distribution of cancer stage among women who participated in the WCEDP.
Measured: 2 years
Patients' costs
out-of-pocket costs borne by patients while undergoing evaluation for an abnormal clinical breast exam
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2021
- Study completion25 Mar 2022
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
- Prospective
- Enrolment
- 17,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rwanda Biomedical Centre, Partners in Health, Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Lydia Pace, MD, MPH, Brigham and Women's Hospital
- Investigators
- Lydia Pace, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258085
- Sponsor's protocol ID
- 2014P002688a
- Status last verified
- Mar 2022
- First submitted
- 4 Feb 2020
- Last updated
- 7 Apr 2022
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System
- ClinicalTrials.gov ID
- NCT04258085
- Acronym / sponsor ID
- 2014P002688a
- Conditions
- Breast Cancer, Benign Breast Disease
- Keywords
- Rwanda, breast cancer, screening, early detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,379 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Rwanda Biomedical Centre, Partners in Health, Breast Cancer Research Foundation
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 6 Feb 2020 (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 observational study evaluates scale-up of a breast cancer early detection program in Rwanda that was initially piloted in a single district. Specifically investigators will examine patient volume, service delivery, loss-to-follow-up rates, and cancer detection rates noted following implementation of scale-up to 3 additional districts. For scaleup, breast cancer screening with CBE was added to a cervical cancer screening initiative, in a combined Women's Cancer Early Detection Program (WCEDP).
Detailed description
Investigators previously conducted a cluster randomized controlled trial of a clinician training program to facilitate prompt evaluation of women with breast symptoms in one rural district of Rwanda. Subsequently, Rwanda Biomedical Centre (RBC) has scaled up the curriculum in 3 districts, adapting the program to integrate CBE screening into a cervical cancer screening initiative. In this study, we will evaluate implementation of this combined screening initiative. Investigators will assess patient volume, services, diagnoses, and loss to follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening plus EMR | – | Other: Early diagnosis program combined with electronic medical recordIndividuals in this group are those residing in districts where health facilities have implemented a breast cancer screening program integrated with cervical cancer screening, the Women's Cancer Early Detection Program (WCEDP). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not 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 women and men 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early diagnosis program combined with electronic medical recordImplementation of early diagnosis approach targeting symptomatic women, combined with use of electronic medical record to facilitate documentation, patient tracking across levels of the health care system, and patient contact | Other | Screening plus EMR |
Primary outcome
Cancer detection rate
Time frame: 2 years
Proportion of patients presenting to health centers who are ultimately diagnosed with cancer; proportion of patients who receive biopsy who are ultimately diagnosed with cancer; proportion of individuals diagnosed with cancer who initially presented with versus without breast symptoms
Loss to follow-up
Time frame: one year
Rates of loss-to-follow up before and after implementation of electronic medical record in districts utilizing breast cancer screening approach; and loss to follow up in districts implementing early diagnosis approach and EMR
Patient volume and services received
Time frame: two years
Number of patients presenting at the health centers, district hospital and referral hospitals
2 secondary outcomes
Breast cancer stage
Time frame: 2 years
Patients' costs
Time frame: 6 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 7 Apr 2022.
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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 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 7 Apr 2022. 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?
Cancer detection rate (time frame: 2 years). 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 7 Apr 2022.