Clinical trials / NCT06721065
Recruiting

A Study of Language Interpretation Solutions for People With Breast Cancer

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…

ClinicalTrials.gov IDNCT06721065
PhaseNA
Enrollment700
SponsorMemorial Sloan Kettering Cancer Center
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.