Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06721065

Conditions

Breast Cancer

Breast Cancer Stage II

Breast Cancer Stage III

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remote Simultaneous Medical Interpreting/RSMI

Remote Consecutive Medical Interpreting/RCMI

Remote Consecutive Video Medical Interpreting/RCVI

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Breast Cancer Stage II

Breast Cancer Stage III

Study ID

NCT06721065

Start date

Dec 2, 2024

Status verified date

May, 2026

Completion date

Dec 2, 2029

Anticipated

Primary completion date

Dec 2, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

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

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

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

Interventions

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.

Remote Consecutive Medical Interpreting/RCMI

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

Remote Consecutive Video Medical Interpreting/RCVI

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Francesca Gany, MD, MS

646-888-8054ganyf@mskcc.org

Lisa Diamond, MD

646-888-8061diamondl@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Monmouth (Consent Only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Fransecsa Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Suffolk- Commack (Consent Only)

Recruiting

Commack, New York, United States, 11725

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Westchester (Consent Only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10035

Contacts

Francesca Gany, MD

646-888-8054

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Franscesca Gany, MD, MS

646-888-8054

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • Breast Cancer
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Language Interpretation
  • Spanish
  • Mandarin
  • Memorial Sloan Kettering Cancer Center
  • 24-350

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-12.