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Recruiting NCT06721065

A Study of Language Interpretation Solutions for People With Breast Cancer

No phase Interventional Breast Cancer Breast Cancer Stage II Breast Cancer Stage III

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote Simultaneous Medical Interpreting/RSMI, Remote Consecutive Medical Interpreting/RCMI, Remote Consecutive Video Medical Interpreting/RCVI.
Who it may be relevant to
Registry conditions: Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

RSMI HEALS (Health Equity Advances Through Language Solutions) (AI)

Overview

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

  • Other Remote Simultaneous Medical Interpreting/RSMI
    Remote 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.
  • Other Remote Consecutive Medical Interpreting/RCMI
    Remote Consecutive Medical Interpreting (RCMI; "audio consecutive"), is the most commonly utilized remote interpreting
  • Other Remote Consecutive Video Medical Interpreting/RCVI
    Remote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter

Primary outcome measures

  • Number of interpretation errors [Time frame: up to 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 8 centers
  • Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
  • Memorial Sloan Kettering Bergen (Consent Only) — Montvale
  • Memorial Sloan Kettering Suffolk- Commack (Consent Only) — Commack
  • Memorial Sloan Kettering Westchester (Consent Only) — Harrison
  • Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre

Identifiers

NCT: NCT06721065 · 24-350

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗