Clinical trial NCT06721065: A Study of Language Interpretation Solutions for People With Breast Cancer
Official title: RSMI HEALS (Health Equity Advances Through Language Solutions) (AI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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 Stage I, II, III, or IV breast cancer (per EMR)
* Will be visiting MSK oncologist for the first or second appointment (per EMR)
* Will be continuing medical oncology visits at MSK (per EMR)
* Agrees to be audio-recorded (per self-report)

Phase 1 Providers

* Breast cancer provider who sees patients (e.g., breast 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

Primary outcomes:
measure: Number of interpretation errors
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent Only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Francesca Gany, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: