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NCT06721065 | RECRUITING | Breast Cancer

A Study of Language Interpretation Solutions for People With Breast Cancer
Sponsor:

Memorial Sloan Kettering Cancer Center

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.

Condition or disease

Breast Cancer

Breast Cancer Stage II

Breast Cancer Stage III

Intervention/treatment

Remote Simultaneous Medical Interpreting/RSMI

Remote Consecutive Medical Interpreting/RCMI

Remote Consecutive Video Medical Interpreting/RCVI

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 640 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : RSMI HEALS (Health Equity Advances Through Language Solutions) (AI)
Actual Study Start Date : 2024-12-02
Estimated Primary Completion Date : 2029-12-02
Estimated Study Completion Date : 2029-12-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study of Language Interpretation Solutions for People With Breast Cancer

Location Details

NCT06721065

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk- Commack (Consent Only)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

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

New York, New York, United States, 10035

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Center, New York, United States, 11553