A Study of Language Interpretation Solutions for People With Breast Cancer
Part of paid clinical trials in Basking Ridge, New Jersey.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT06721065
- Status
- Recruiting
Conditions
- Breast Cancer
- Breast Cancer Stage II
- Breast Cancer Stage III
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Remote Simultaneous Medical Interpreting/RSMI — OTHERRemote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter, which holds tremendous promise for closely approximating a same language encounter, decreasing interpreting errors, and improving outcomes.
- Remote Consecutive Medical Interpreting/RCMI — OTHERRemote Consecutive Medical Interpreting (RCMI; "audio consecutive"), is the most commonly utilized remote interpreting
- Remote Consecutive Video Medical Interpreting/RCVI — OTHERRemote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter
Study Details
The study will be conducted in 2 overlapping phases. In Phase 1, there will be a 3-arm randomized controlled trial of Remote Simultaneous Medical Interpreting/RSMI (Arm 1), versus Remote Consecutive Medical Interpreting/RCMI (Arm 2) and versus Remote Consecutive Video Medical Interpreting/RCVI (Arm 3) in breast cancer outpatient clinical encounters with Spanish- and Mandarin-speaking patients with Limited English Proficiency/LEP (Stages II and III disease) and English- speaking providers (who do not speak Spanish/Mandarin). In Phase 2, there will be a sequential mixed-methods explanatory, multi-stakeholder process evaluation to gather implementation potential data.
Key Dates
- Start date
- Dec 2, 2024
- Status verified
- May 2026
- Primary completion
- Dec 2, 2029
- Completion
- Dec 2, 2029
Study Design
- Enrollment
- 700 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Phase I: Remote Simultaneous Medical Interpreting/RSMI (Arm 1)This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers
- Experimental: Phase I: Remote Consecutive Medical Interpreting/RCMI (Arm 2)This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers
- Experimental: Phase I: Remote Consecutive Video Medical Interpreting/RCVI (Arm 3)This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers
- Experimental: Phase II: CFIR mixed-methods explanatory, multi- stakeholder process evaluationWill examine RSMI utilization (Arm 1 participants only and clinic staff), intervention barriers and facilitators, and implementation potential
Primary Outcome Measure
Number of interpretation errors [ Time Frame: up to 30 days ]
Central Contacts
- Francesca Gany, MD, MS646-888-8054
- Lisa Diamond, MD646-888-8061
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) | Basking Ridge | New Jersey | 07920 | Francesca Gany, MD, MS 646-888-8054 |
| Memorial Sloan Kettering Monmouth (Consent Only) | Middletown | New Jersey | 07748 | Fransecsa Gany, MD, MS 646-888-8054 |
| Memorial Sloan Kettering Bergen (Consent Only) | Montvale | New Jersey | 07645 | Francesca Gany, MD, MS 646-888-8054 |
| Memorial Sloan Kettering Suffolk- Commack (Consent Only) | Commack | New York | 11725 | Francesca Gany, MD, MS 646-888-8054 |
| Memorial Sloan Kettering Westchester (Consent Only) | Harrison | New York | 10604 | Francesca Gany, MD, MS 646-888-8054 |
| Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities) | New York | New York | 10035 | Francesca Gany, MD 646-888-8054 |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | Francesca Gany, MD, MS 646-888-8054 |
| Memorial Sloan Kettering Nassau (All Protocol Activities) | Rockville Centre | New York | 11553 | Franscesca Gany, MD, MS 646-888-8054 |
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