Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Remote Simultaneous Medical Interpreting/RSMI (Arm 1) | Experimental | This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers |
|
| Phase I: Remote Consecutive Medical Interpreting/RCMI (Arm 2) | Experimental | This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers |
|
| Phase I: Remote Consecutive Video Medical Interpreting/RCVI (Arm 3) | Experimental | This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers |
|
| Phase II: CFIR mixed-methods explanatory, multi- stakeholder process evaluation | Experimental | Will examine RSMI utilization (Arm 1 participants only and clinic staff), intervention barriers and facilitators, and implementation potential |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Simultaneous Medical Interpreting/RSMI | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of interpretation errors | Via 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) | up to 30 days |
Not provided
Not provided
Inclusion Criteria:
Phase I Patients
Phase 1 Providers
Exclusion Criteria:
Phase 1 Patients
Phase I Providers
Phase 2 (clinic staff only; Phase 1 patient participants follow above criteria)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Gany, MD, MS | Contact | 646-888-8054 | ganyf@mskcc.org | |
| Lisa Diamond, MD | Contact | 646-888-8061 | diamondl@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Francesca Gany, MD, MS | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Remote Consecutive Medical Interpreting/RCMI | Other | Remote Consecutive Medical Interpreting (RCMI; "audio consecutive"), is the most commonly utilized remote interpreting |
|
| Remote Consecutive Video Medical Interpreting/RCVI | Other | Remote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter |
|
| Memorial Sloan Kettering Monmouth (Consent Only) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Consent Only) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk- Commack (Consent Only) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Consent Only) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities) | Recruiting | New York | New York | 10035 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (All Protocol Activities) | Recruiting | Rockville Centre | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided