A Study of Language Interpretation Solutions for People With Breast Cancer

May 11, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Francesca Gany, MD, MS
  • Phone Number: 646-888-8054
  • Email: ganyf@mskcc.org

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Consent Only)
        • Contact:
          • Francesca Gany, MD, MS
          • Phone Number: 646-888-8054
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Consent Only)
        • Contact:
          • Fransecsa Gany, MD, MS
          • Phone Number: 646-888-8054
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Consent only)
        • Contact:
          • Francesca Gany, MD, MS
          • Phone Number: 646-888-8054
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk- Commack (Consent Only)
        • Contact:
          • Francesca Gany, MD, MS
          • Phone Number: 646-888-8054
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Consent only)
        • Contact:
          • Francesca Gany, MD, MS
          • Phone Number: 646-888-8054
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Francesca Gany, MD, MS
          • Phone Number: 646-888-8054
      • New York, New York, United States, 10035
        • Recruiting
        • Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities)
        • Contact:
          • Francesca Gany, MD
          • Phone Number: 646-888-8054
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All protocol activities)
        • Contact:
          • Franscesca Gany, MD, MS
          • Phone Number: 646-888-8054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Recruitment will be conducted at three cancer clinics, the Ralph Lauren Center for Cancer Care (RLC), the MSK Breast and Imaging Center (BAIC), and MSK Nassau, sites with which MSK has collaborated extensively in their prior work

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I: Remote Simultaneous Medical Interpreting/RSMI (Arm 1)
This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers
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.
Experimental: Phase I: Remote Consecutive Medical Interpreting/RCMI (Arm 2)
This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers
Other: Remote Consecutive Medical Interpreting/RCMI
Remote Consecutive Medical Interpreting (RCMI; "audio consecutive"), is the most commonly utilized remote interpreting
Experimental: Phase I: Remote Consecutive Video Medical Interpreting/RCVI (Arm 3)
This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers
Other: Remote Consecutive Video Medical Interpreting/RCVI
Remote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter
Experimental: Phase II: CFIR mixed-methods explanatory, multi- stakeholder process evaluation
Will examine RSMI utilization (Arm 1 participants only and clinic staff), intervention barriers and facilitators, and implementation potential
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Francesca Gany, MD, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

December 2, 2029

Study Completion (Estimated)

December 2, 2029

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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