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Breast CancerNCT06812208

Strategies to Decentralize Breast Ultrasound in Rwanda

A study testing Teleultrasound with Philips Lumify ultrasound probes and Reacts software and Asynchronous virtual feedback in people with Breast Cancer and Early Detection of Cancer, run by Brigham and Women's Hospital at 1 site in Rwanda.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Teleultrasound with Philips Lumify ultrasound probes and Reacts software and Asynchronous virtual feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,792 participants
Where
1 siteRwanda
Study dates
Jan 2027to 30 Nov 2029
Phase
Interventional

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lydia E Pace, MD, MPH contact

4154657223

lpace@bwh.harvard.edu

Rwanda1 site
  • Partners in Health (Inshuti Mu Buzima)

    Butaro

Other trials in Rwanda

About this study

Official title: Implementation Strategies to Decentralize Breast Ultrasound Services and Facilitate Timely Breast Cancer Diagnoses in Rwanda

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.

Read the detailed description

Breast cancer cases and deaths are rising rapidly in low- and middle-income countries (LMIC), including in sub-Saharan Africa, where most women with breast cancer are diagnosed with advanced-stage disease. Largely because of late-stage presentations, breast cancer survival in sub-Saharan Africa is poor. To address these global breast cancer inequities, the World Health Organization has emphasized the need for expanded access to breast cancer diagnostics in LMIC, and particularly calls for strategies that decentralize diagnostic testing to primary- and secondary-level health facilities while maintaining care quality. Diagnostic breast ultrasound (U/S) is an evidence-based intervention that is essential in evaluation of palpable breast abnormalities, including for determining which lesions require biopsy. However, diagnostic breast U/S is typically only provided by radiologists at LMIC referral facilities and is hard for low-income rural patients to access, impeding quality, equity, timeliness and efficiency of breast evaluation and contributing to diagnostic inefficiencies and delays. To address this issue, Rwanda's chief health implementation agency (Rwanda Biomedical Centre) has called for decentralized provision of breast U/S at district hospitals through task-shifting to non-radiologist clinicians. Supportive supervision is regarded as essential for successful task-shifting. However, scalable strategies for clinical supervision of non-radiologist clinicians to ensure sustained provision of high-quality decentralized breast ultrasound have not been investigated. The investigators' preliminary work training a small group of non-radiologist clinicians in Rwanda suggests that virtual support through electronically shared images and asynchronous feedback is feasible and potentially beneficial after intensive and prolonged in person training. However, supervision with real-time teleultrasound technology could be more effective in facilitating ultrasound provision and quality in a broader population of district hospital clinicians receiving shortened in-person training.

The objective of this research project is to compare 2 implementation strategies (teleultrasound supervision and asynchronous virtual feedback) to facilitate decentralized breast ultrasound at Rwandan district hospitals. The investigators will conduct a hybrid Type 2 implementation-effectiveness trial to accomplish this.

In Aim 1, the investigators will compare the strategies' impact on penetration of guideline-concordant diagnostic breast ultrasound at district hospitals (implementation effectiveness).

In Aim 2, the investigators will compare the strategies' impact on trainee-performed breast U/S image quality at district hospitals (clinical effectiveness).

In Aim 3, the investigators will estimate the implementation strategies' costs and cost-effectiveness in facilitating high-quality breast U/S, as well as examine downstream cost offsets associated with decentralized breast U/S.

These findings will directly inform breast cancer diagnosis pathways in Rwanda, shape the workforce and credentialing processes for breast U/S, and expand patients' access to this service. In addition, this project will contribute to global understanding of feasible, contextually appropriate and effective strategies to increase access to breast cancer diagnostic services (particularly imaging) in LMIC- a topic of major global interest in light of rapidly rising breast cancer incidence and mortality in LMIC.

Being tested
Teleultrasound with Philips Lumify ultrasound probes and Reacts software, Asynchronous virtual feedback
Keywords
breast ultrasound, implementation strategies, low and middle income countries, breast cancer early detection, teleultrasound, Rwanda
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teleultrasound with Philips Lumify ultrasound probes and Reacts softwareBehavioural

    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.

  • Asynchronous virtual feedbackBehavioural

    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.

Study groups in NCT06812208
Study groupRoleWhat they receive
TeleultrasoundExperimentalArm 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.
Receives: Behavioral: Teleultrasound with Philips Lumify ultrasound probes and Reacts software
Asynchronous virtual feedbackActive comparatorArm 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.
Receives: Behavioral: Asynchronous virtual feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

  2. 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.

    Measured: 12 months

Secondary outcomes (7)
  1. Fidelity to assigned clinical support implementation strategy

    Out of total number of ultrasounds performed, % performed using the assigned clinical support strategy (teleultrasound or asynchronous feedback)

    Measured: 12 months

  2. Adoption of breast U/S by clinicians

    % of weeks in which ultrasound is provided

    Measured: 12 months

  3. Maintenance of breast U/S provision

    % of weeks that U/S is provided

    Measured: 13-24 months

  4. Maintenance of breast U/S volume

    Number of U/S scans per week

    Measured: 13-24 months

  5. Feasibility of implementation strategies

    4-item instrument measuring the feasibility of an intervention, included in clinician and site leadership surveys. Scores can range from 0-20, with higher scores indicating greater feasibility.

    Measured: Months 3,6,12

  6. Appropriateness of implementation strategies

    4-item measure of appropriateness of intervention, included in clinician and site leadership surveys. Score can range from 0-20. Higher scores indicate greater appropriateness.

    Measured: Months 3,6,12

  7. Sustainment of implementation strategies

    3-item Provider REport of Sustainment Scale (PRESS) included in clinician and leadership surveys. Each item is scored 0 = not at all, 1 = to a slight extent, 2 = to a moderate extent, 3 = to a great extent, and 4 = to a very great extent. Minimum score=0 (not sustained); maximum score=12 (sustained to a great degree).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study startJan 2027 (estimated)
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion30 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,792 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812208
Sponsor's protocol ID
2024P002311
Status last verified
Jun 2026
First submitted
25 Jan 2025
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data sharing will only be implemented in accordance with Rwanda's data security regulations. No individual-level data will be shared.

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