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Recruiting

NCT Number: NCT06721065

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 Spanish/Mandarin). In Phase 2, there will be a sequential mixed-methods explanatory, multi-stakeholder process evaluation to gather implementation potential data.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Simultaneous Medical Interpreting/RSMI

Other

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.

Remote Consecutive Medical Interpreting/RCMI

Other

Remote Consecutive Medical Interpreting (RCMI; "audio consecutive"), is the most commonly utilized remote interpreting

Remote Consecutive Video Medical Interpreting/RCVI

Other

Remote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter

Primary outcomes

  1. Number of interpretation errors

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Gany, MD, MS

CONTACT

[email protected]

646-888-8054

Lisa Diamond, MD

CONTACT

[email protected]

646-888-8061

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 6, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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