Strategies to Decentralize Breast Ultrasound in Rwanda

NCT06812208 | Not Yet Recruiting

• 1 other identifier: 2024P002311
• Study Type: interventional
• Target: 1,792
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnosing breast cancer early is critical to reduce preventable breast cancer deaths in sub-Saharan Africa. This can be done in part through increasing patients' access to breast ultrasound, which is essential for evaluating breast masses. However, ultrasound is typically provided only by radiologists at urban referral hospitals. Training clinicians at rural district hospitals who are not radiologists could increase patients' access to breast ultrasound, but strategies to support and supervise these clinicians and ensure they are providing high-quality ultrasound services has not been studied. This project will examine the effectiveness and cost of two strategies for training non-radiologist clinicians to perform breast ultrasound in Rwandan district hospitals.

Conditions

Breast Cancer; Early Detection of Cancer; Ultrasonography

Keywords

breast ultrasound; implementation strategies; low and middle income countries; breast cancer early detection; teleultrasound; Rwanda

Outcome Measures

Primary Outcomes (2)

• Penetration of diagnostic breast ultrasound provision in district hospitals

  Number of women receiving breast U/S / number of individuals evaluated at the district hospital with a breast mass

  12 months

• Trainee-provided breast ultrasound quality

  Image quality score assessed by a blind third-party radiologist using a 15-item quality metric. Score is currently being validated and finalized.

  12 months

Secondary Outcomes (7)

• Fidelity to assigned clinical support implementation strategy

  12 months

• Adoption of breast U/S by clinicians

  12 months

• Maintenance of breast U/S provision

  13-24 months

• Maintenance of breast U/S volume

  13-24 months

• Feasibility of implementation strategies

  Months 3,6,12

Study Arms (2)

Teleultrasound

EXPERIMENTAL

Arm 1 hospitals will receive teleultrasound supervision using secure Reacts software which allows clinical supervisors to view ultrasound images and provide scanning feedback in real-time.

Behavioral: Teleultrasound with Philips Lumify ultrasound probes and Reacts software

Asynchronous virtual feedback

ACTIVE COMPARATOR

Arm 2 hospitals will receive asynchronous virtual feedback in which trainees will upload static images to a shared drive and mentors will email feedback within 24 hours.

Behavioral: Asynchronous virtual feedback

Interventions

Teleultrasound with Philips Lumify ultrasound probes and Reacts software BEHAVIORAL

Clinicians at hospitals randomized to Arm 1 will be provided with Reacts licenses and trained to use Reacts with Philips Lumify devices immediately following the baseline training. Each hospital will be assigned to 2-3 radiologist supervisors (typically 1 Rwandan, 1 U.S.-based), with at least one available on each designated U/S clinic day to provide real-time teleultrasound mentorship. Clinician trainees scan the breast, document their independent findings and management plan in the study REDCap database, and then "call" the supervisor using Reacts. Reacts permits supervisor and trainee to see each other virtually; the supervisor can also view live U/S images and the trainee's probe and hand position to provide real-time feedback.

Teleultrasound

Asynchronous virtual feedback BEHAVIORAL

Clinicians at Arm 2 hospitals will save static images, with or without video at clinicians' discretion, onto the Philips Lumify tablets. These will be uploaded to a secure internet-based folder with case descriptions, and assigned U.S.- and Rwanda-based experts will be notified that images are available. Experts will review images within 24 hours and email feedback to trainees on imaging quality/ technique and management; trainees can also email questions.

Asynchronous virtual feedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• District hospital in Rwanda;
• Already implementing the Women's Cancer Early Detection Program in their districts (i.e. clinicians in health centers and hospitals in the district have received the nationally-sponsored trainings in breast cancer early detection and cervical cancer screening);
• Already using the WCEDP electronic medical record in health centers and the district hospital, or prepared to start using it.

You may not qualify if:

• \. Already providing routine breast ultrasound in the district hospital.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Partners in Health: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• University of Pennsylvania: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Obafemi Awolowo University: collaborator
• Kaiser Permanente: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Partners in Health (Inshuti Mu Buzima)

Butaro, Rwanda

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lydia E Pace, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia E Pace, MD, MPH

CONTACT

4154657223; lpace@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research team members who are evaluating the strategies will not know which district hospitals belong to each arm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: This is a Type 2 hybrid implementation-effectiveness study designed to compare the effect of synchronous teleultrasound mentorship versus asynchronous virtual feedback (implementation strategies) on penetration of breast ultrasound into district hospital practice (implementation outcome) and ultrasound quality (clinical outcome).

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 6, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): November 30, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)