A Study of Language Interpretation Solutions for People With Breast Cancer
Recruiting · NCT06721065 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 breast cancer or gastrointestinal (per EMR)
- Will be visiting MSK oncology teams for the first or second appointment (per EMR)
- Agrees to be audio-recorded (per self-report)
- Phase 1 Providers
- Breast or gastrointestinal cancer provider who sees patients (e.g., breast or gastrointestinal 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)
Exclusion criteria
- 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
Where it is running
8 locations listed across 2 US states.
- 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