A Study of Language Interpretation Solutions for People With Breast Cancer
- Conditions
- Breast CancerBreast Cancer Stage IIBreast Cancer Stage III
- Registration Number
- NCT06721065
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 640
Phase I Patients
- Age >=18 years (per EMR)
- Preferred language for healthcare is Spanish or Mandarin (per self-report)
- Limited English Proficient; cannot speak English "very well" (per self-report)
- Diagnosis of Stage I, II, III, or IV breast cancer (per EMR)
- Will be visiting MSK oncologist for the first or second appointment (per EMR)
- Will be continuing medical oncology visits at MSK (per EMR)
- Agrees to be audio-recorded (per self-report)
Phase 1 Providers
- Breast cancer provider who sees patients (e.g., breast oncologists, advanced practice providers, and/or nurses)
- Does not speak Spanish and/or Mandarin; providers who speak one language and not the other may participate (e.g., speaks Spanish but not Mandarin) (per self-report)
- Agrees to be audio-record (per self-report) Phase 2 (clinic staff only; patient participants will be drawn from Phase 1)
- Is a staff member who works/worked in one of the study clinic sites during the period of Phase 1 RCT study activities
- Agrees to be audio-recorded (per self-report)
Phase 1 Patients
- Has significant psychiatric disturbance (i.e., acute psychiatric symptoms) sufficient to preclude completion of the assessments, interviews, or informed consent (per EMR, patient's care team, or study team)
- Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patients, care team, or study team)
Phase I Providers
- None
Phase 2 (clinic staff only; Phase 1 patient participants follow above criteria)
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of interpretation errors up to 30 days Via translation and transcription of audio recordings, errors will be determined in the interpretation of medical facts made in each of the RCT arms during Study Visit 1 (post- diagnosis)
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (8)
Memorial Sloan Kettering Basking Ridge (Consent Only)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent Only)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent Only)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk- Commack (Consent Only)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent Only)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
🇺🇸Rockville Centre, New York, United States