A Study of Language Interpretation Solutions for People With Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Breast Cancer Stage II; Breast Cancer; Breast Cancer Stage III

Treatments: Other: Remote Consecutive Video Medical Interpreting/RCVI; Other: Remote Simultaneous Medical Interpreting/RSMI; Other: Remote Consecutive Medical Interpreting/RCMI

Study type: Interventional

Funder types: Other

Identifiers

NCT06721065

24-350

Details and patient eligibility

About

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.

Enrollment: 640 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

640 participants in 4 patient groups

Phase I: Remote Simultaneous Medical Interpreting/RSMI (Arm 1)

Experimental group

Description:

This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers

Treatment:

Other: Remote Simultaneous Medical Interpreting/RSMI

Phase I: Remote Consecutive Medical Interpreting/RCMI (Arm 2)

Experimental group

Description:

This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers

Treatment:

Other: Remote Consecutive Medical Interpreting/RCMI

Phase I: Remote Consecutive Video Medical Interpreting/RCVI (Arm 3)

Experimental group

Description:

This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers

Treatment:

Other: Remote Consecutive Video Medical Interpreting/RCVI

Phase II: CFIR mixed-methods explanatory, multi- stakeholder process evaluation

Experimental group

Description:

Will examine RSMI utilization (Arm 1 participants only and clinic staff), intervention barriers and facilitators, and implementation potential

Treatment:

Other: Remote Simultaneous Medical Interpreting/RSMI