RECRUITING

A Study of Language Interpretation Solutions for People With Breast Cancer

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Conditions

Breast CancerBreast Cancer Stage IIBreast Cancer Stage IIILanguage InterpretationSpanishMandarinMemorial Sloan Kettering Cancer Center24-350

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-02
Study Completion:2029-12-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06721065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>=18 years (per EMR)
  2. * Preferred language for healthcare is Spanish or Mandarin (per self-report)
  3. * Limited English Proficient; cannot speak English "very well" (per self-report)
  4. * Diagnosis of Stage II or III breast cancer within the past two months (per EMR)
  5. * Has completed their first appointment with their medical oncologist (per EMR)
  6. * Will be continuing medical oncology visits at MSK (per EMR)
  7. * Agrees to be audio-recorded (per self-report)
  8. * Breast cancer provider who sees patients (e.g., breast oncologists, advanced practice providers, and/or nurses)
  9. * 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)
  10. * Agrees to be audio-record (per self-report) Phase 2 (clinic staff only; patient participants will be drawn from Phase 1)
  11. * Is a staff member who works/worked in one of the study clinic sites during the period of Phase 1 RCT study activities
  12. * Agrees to be audio-recorded (per self-report)
  1. * 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)
  2. * 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)
  3. * None
  4. * None

Contacts and Locations

Study Contact

Francesca Gany, MD, MS
CONTACT
646-888-8054
ganyf@mskcc.org
Lisa Diamond, MD
CONTACT
646-888-8061
diamondl@mskcc.org

Principal Investigator

Francesca Gany, MD, MS
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk- Commack (Consent Only)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
United States
Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities)
New York, New York, 10035
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Francesca Gany, MD, MS, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-02
Study Completion Date2029-12-02

Study Record Updates

Study Start Date2024-12-02
Study Completion Date2029-12-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Cancer
  • Breast Cancer Stage II
  • Breast Cancer Stage III