Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05364138 |
| Other study ID # |
2021P002943 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 31, 2023 |
| Est. completion date |
March 30, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Brigham and Women's Hospital |
| Contact |
Lydia Pace, MD, MPH |
| Phone |
4154657223 |
| Email |
lpace[@]bwh.harvard.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
