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A Study of Language Interpretation Solutions for People With Breast Cancer

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06721065
Enrollment
700
Registered
2024-12-06
Start date
2024-12-02
Completion date
2029-12-02
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERRemote 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.

OTHERRemote Consecutive Medical Interpreting/RCMI

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

OTHERRemote Consecutive Video Medical Interpreting/RCVI

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

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of interpretation errorsup to 30 daysVia 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)

Countries

United States

Contacts

CONTACTFrancesca Gany, MD, MS
ganyf@mskcc.org646-888-8054
CONTACTLisa Diamond, MD
diamondl@mskcc.org646-888-8061
PRINCIPAL_INVESTIGATORFrancesca Gany, MD, MS

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026