Breast CancerNCT06721065
A Study of Language Interpretation Solutions for People With Breast Cancer
A study testing Remote Simultaneous Medical Interpreting/RSMI, Remote Consecutive Medical Interpreting/RCMI and Remote Consecutive Video Medical Interpreting/RCVI in people with Breast Cancer and Breast Cancer Stage II, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III
- What is being tested?
- Remote Simultaneous Medical Interpreting/RSMI, Remote Consecutive Medical Interpreting/RCMI and Remote Consecutive Video Medical Interpreting/RCVI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 8 sitesUnited States
- Study dates
- 2 Dec 2024to 2 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 breast cancer or gastrointestinal (per EMR)
- Will be visiting MSK oncology teams for the first or second appointment (per EMR)
Show all 13Show fewer
- Agrees to be audio-recorded (per self-report)
- Phase 1 Providers
- Breast or gastrointestinal cancer provider who sees patients (e.g., breast or gastrointestinal 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)
Who cannot join
- 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 locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Suffolk- Commack (Consent Only)
Commack, New York, 11725
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Fransecsa Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities)
New York, New York, 10035
Francesca Gany, MD, 646-888-8054
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11553
Franscesca Gany, MD, MS, 646-888-8054
About this study
Official title: RSMI HEALS (Health Equity Advances Through Language Solutions) (AI)
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.
- Being tested
- Remote Simultaneous Medical Interpreting/RSMI, Remote Consecutive Medical Interpreting/RCMI, Remote Consecutive Video Medical Interpreting/RCVI
- Keywords
- Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III, Language Interpretation, Spanish, Mandarin, Memorial Sloan Kettering Cancer Center, 24-350
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Simultaneous Medical Interpreting/RSMIOther
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.
Remote Consecutive Medical Interpreting/RCMIOther
Remote Consecutive Medical Interpreting (RCMI; "audio consecutive"), is the most commonly utilized remote interpreting
Remote Consecutive Video Medical Interpreting/RCVIOther
Remote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Remote Simultaneous Medical Interpreting/RSMI |
| 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 Receives: Other: Remote Consecutive Medical Interpreting/RCMI |
| 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 Receives: Other: Remote Consecutive Video Medical Interpreting/RCVI |
| 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 Receives: Other: Remote Simultaneous Medical Interpreting/RSMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start2 Dec 2024
- Primary completion2 Dec 2029 (estimated)
- Study completion2 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Gany, MD, MS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721065
- Sponsor's protocol ID
- 24-350
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RSMI HEALS (Health Equity Advances Through Language Solutions) (AI)
- ClinicalTrials.gov ID
- NCT06721065
- Acronym / sponsor ID
- 24-350
- Keywords
- Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III, Language Interpretation, Spanish, Mandarin, Memorial Sloan Kettering Cancer Center, 24-350
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 2 Dec 2029 (estimated)
- Study completion
- 2 Dec 2029 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I: Remote Simultaneous Medical Interpreting/RSMI (Arm 1) | Experimental | Other: Remote Simultaneous Medical Interpreting/RSMIThis 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 | Other: Remote Consecutive Medical Interpreting/RCMIThis 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 | Other: Remote Consecutive Video Medical Interpreting/RCVIThis 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 | Other: Remote Simultaneous Medical Interpreting/RSMIWill examine RSMI utilization (Arm 1 participants only and clinic staff), intervention barriers and facilitators, and implementation potential |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 breast cancer or gastrointestinal (per EMR)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Simultaneous Medical Interpreting/RSMIRemote 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. | Other | Phase I: Remote Simultaneous Medical Interpreting/RSMI (Arm 1), Phase II: CFIR mixed-methods explanatory, multi- stakeholder process evaluation |
| Remote Consecutive Medical Interpreting/RCMIRemote Consecutive Medical Interpreting (RCMI; "audio consecutive"), is the most commonly utilized remote interpreting | Other | Phase I: Remote Consecutive Medical Interpreting/RCMI (Arm 2) |
| Remote Consecutive Video Medical Interpreting/RCVIRemote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter | Other | Phase I: Remote Consecutive Video Medical Interpreting/RCVI (Arm 3) |
Primary outcome
Number of interpretation errors
Time frame: up to 30 days
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Gany, MD, MS principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Simultaneous Medical Interpreting/RSMI, Remote Consecutive Medical Interpreting/RCMI and Remote Consecutive Video Medical Interpreting/RCVI in people with Breast Cancer and Breast Cancer Stage II, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Gany, MD, MS (646-888-8054, ganyf@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of interpretation errors (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.