Language Interpretation Solutions for Breast Cancer

Recruiting at 7 trial locations

Overseen By Lisa Diamond, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Psychiatric disturbance, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods of providing language interpretation services for breast cancer patients who primarily speak Spanish or Mandarin and have limited English proficiency. It seeks to identify the best method among three options: remote consecutive medical interpreting (RCMI, done after the speaker pauses), remote consecutive video medical interpreting (RCVI), and remote simultaneous medical interpreting (RSMI, done in real-time). The trial seeks patients with Stage II or III breast cancer who are visiting their medical oncologist for the first or second time. As an unphased trial, this study offers a unique opportunity to enhance communication and care for non-English speaking patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these language interpretation solutions are safe for breast cancer patients with limited English proficiency?

Research has shown that remote medical interpreting methods, such as Remote Consecutive Medical Interpreting (RCMI), Remote Consecutive Video Medical Interpreting (RCVI), and Remote Simultaneous Medical Interpreting (RSMI), are generally well-received by patients. Studies have examined their ability to improve communication without compromising safety. The available research does not report any specific negative effects associated with these methods. They serve as a safe and accurate alternative to traditional in-person interpreting, without introducing new safety concerns. This indicates that participants in these trials are not exposed to additional risks from the interpreting methods being tested. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring innovative language interpretation methods for breast cancer patients who have limited English proficiency (LEP). Unlike traditional interpreters who are physically present, the trial is testing remote interpreting solutions, including Remote Consecutive Medical Interpreting (RCMI), Remote Consecutive Video Medical Interpreting (RCVI), and Remote Simultaneous Medical Interpreting (RSMI). These methods aim to provide more accessible, flexible, and potentially cost-effective communication between non-English-speaking patients and their healthcare providers. By evaluating these remote solutions, the trial hopes to identify effective ways to improve patient understanding and participation in their treatment plans, ultimately enhancing their overall healthcare experience.

What evidence suggests that this trial's language interpretation solutions could be effective for breast cancer patients with limited English proficiency?

Research has shown that remote medical interpreters can greatly improve patient care, especially for those who have difficulty with English. This trial will compare different remote interpreting methods. Participants may receive Remote Simultaneous Medical Interpreting (RSMI), which studies indicate often leads to fewer medical mistakes and is quicker than other methods. Other participants will receive Remote Consecutive Medical Interpreting (RCMI) or Remote Consecutive Video Medical Interpreting (RCVI), both of which also improve communication between patients and healthcare providers, reducing language barriers. Overall, these methods effectively enhance healthcare experiences for patients who are not fluent in English. ^{1 2 4 6 7}

Who Is on the Research Team?

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for Spanish and Mandarin-speaking breast cancer patients with limited English proficiency, specifically those in stages II and III of the disease. They will be working with English-speaking healthcare providers who do not speak Spanish or Mandarin.

Inclusion Criteria

Phase 1 Providers: 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

I am a provider who does not speak Spanish and/or Mandarin.

Exclusion Criteria

Phase I Providers: None

I do not have severe psychiatric issues that would stop me from completing study requirements.

Phase 2 (clinic staff only; Phase 1 patient participants follow above criteria): None

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Treatment

3-arm randomized controlled trial of Remote Simultaneous Medical Interpreting (RSMI), Remote Consecutive Medical Interpreting (RCMI), and Remote Consecutive Video Medical Interpreting (RCVI) in breast cancer outpatient clinical encounters

4 weeks

Study Visit 1 (post-diagnosis)

Phase 2: Evaluation

Sequential mixed-methods explanatory, multi-stakeholder process evaluation to gather implementation potential data

4 weeks

Follow-up

Participants are monitored for interpretation errors and implementation potential

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Consecutive Medical Interpreting/RCMI
• Remote Consecutive Video Medical Interpreting/RCVI
• Remote Simultaneous Medical Interpreting/RSMI

Trial Overview

The study compares three types of remote interpreting services during medical appointments: simultaneous interpreting (RSMI), consecutive interpreting (RCMI), and video-based consecutive interpreting (RCVI). It's a randomized trial, meaning participants are randomly assigned to one of these methods.

How Is the Trial Designed?

Group I: Phase II: CFIR mixed-methods explanatory, multi- stakeholder process evaluation Experimental Treatment 1 Intervention

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

Group II: Phase I: Remote Simultaneous Medical Interpreting/RSMI (Arm 1) Experimental Treatment 1 Intervention

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

Group III: Phase I: Remote Consecutive Video Medical Interpreting/RCVI (Arm 3) Experimental Treatment 1 Intervention

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

Group IV: Phase I: Remote Consecutive Medical Interpreting/RCMI (Arm 2) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Breast MRI is primarily used as a complementary tool to mammography and ultrasonography, accounting for 43.6% of cases, and is also important for staging breast cancer in 25.1% of cases.

Despite strong evidence supporting its effectiveness, especially for screening high-risk patients (17.4%), breast MRI remains underutilized in Brazil, indicating a potential gap in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications for breast magnetic resonance imaging at a referral center for the diagnosis and treatment of breast cancer in Brazil. Ferreira, SS., Campos, AM., Fernandes, PL., et al.[2022]

eHealth interventions, like televisits and remote patient monitoring, can significantly improve access to cancer care for patients in both rural and urban communities by overcoming barriers to timely screening and treatment.

Successful implementation of eHealth programs has been shown to enhance patient-provider communication and transform care delivery, ultimately leading to better quality cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to Care: Using eHealth to Limit Location-Based Barriers for Patients With Cancer. Baldwin-Medsker, A., Holland, J., Rodriguez, ES.[2021]

The remote-simultaneous interpretation service led to significantly more communication during postpartum visits, with 10% more physician utterances and 28% more mother utterances compared to traditional interpretation methods.

Both mothers and physicians preferred the remote-simultaneous interpretation service, which also resulted in fewer inaccuracies in communication, suggesting it enhances understanding in medical encounters for non-English-speaking patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eliminating language barriers for non-English-speaking patients. Hornberger, JC., Gibson, CD., Wood, W., et al.[2021]

In a study of 1116 breast cancer patients, preoperative staging MRI detected non-index lesions (NILs) in 24% and occult cancers (OCs) in 7.5%, highlighting the MRI's effectiveness in identifying additional malignancies that conventional imaging might miss.

The study found that patients without BRCA mutations had a higher likelihood of having NILs, suggesting that genetic factors may influence the detection of additional lesions, and emphasizes the need for further research in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical findings and outcomes of MRI staging of breast cancer in a diverse population. Raghavendra, A., Wecsler, J., Ji, L., et al.[2020]

In a study of 334 patients with confirmed breast cancer, preoperative MRI showed a very low re-operation rate of only 1.2% after lumpectomy, indicating its effectiveness in accurately mapping tumor extent.

MRI identified multicentricity in 7.7% of patients and detected occult contralateral cancers in 3.6%, which mammography missed 77.8% of the time, highlighting MRI's superior sensitivity for detecting additional lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative breast MRI for locoregional staging. Hollingsworth, AB., Stough, RG.[2019]

Current evidence suggests that breast MRI improves outcomes primarily for BRCA mutation carriers and women with a strong family history of breast cancer, but its routine use in newly diagnosed patients remains debated.

MRI may offer potential benefits in evaluating responses to neoadjuvant therapy, indicating its role in predicting treatment effectiveness, although further research is needed to clarify its impact on surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 2013 Society of Surgical Oncology Susan G. Komen for the Cure Symposium: MRI in breast cancer: where are we now? McLaughlin, S., Mittendorf, EA., Bleicher, RJ., et al.[2020]

The study involved 40 breast cancer patients and demonstrated that a telemedicine system integrated with multimedia and AI can effectively support remote decision-making in oncology, achieving high accuracy rates of 94.1% for surgical planning and over 96% for chemotherapy and hormone therapy recommendations.

Despite the overall success, there were some cases (4 out of 40) where the AI-supported decisions were not as clear, particularly for surgical treatment proposals, highlighting the need for careful consideration in non-malignant cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote AI Supported E-Multidisciplinary Oncology Conference in Breast Cancer as a Technology and Method to Optimize Outcomes in the Peripheries. Mammas, CS., Mamma, AS., Papaxoinis, G., et al.[2022]

Telehealth has proven benefits such as early diagnosis, reduced travel costs, and improved patient satisfaction, but its uptake in remote areas like the NT has been limited due to inadequate internet access.

The successful implementation of telehealth in three remote clinics, facilitated by high-end satellite internet, has transformed patient care by enabling video consultations and remote diagnostics, leading to earlier identification of health issues and better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth: A Game Changer - Closing the Gap in Remote Indigenous Health in Three Remote Homeland Communities in the Laynhapuy Homelands, East Arnhem, Northern Australia. St Clair, M., Murtagh, D., Kelly, J., et al.[2021]

In a study of 380 patients seeking second opinions on breast imaging, nearly 47.4% had differing radiologic impressions compared to outside institutions, highlighting the importance of expert review.

The reinterpretation of imaging led to changes in management plans for 53.5% of patients, including the detection of six new malignancies, demonstrating the critical role of second opinions in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Imaging Second Opinions Impact Surgical Management. Spivey, TL., Carlson, KA., Janssen, I., et al.[2022]

A remote iconographic follow-up system for wound care in an oncology center has successfully supported over 40 patients, allowing expert nurses to analyze photographs of wounds and coordinate care without requiring patients to travel.

A satisfaction survey from 2018 showed that over 95% of both patients and professionals were fully satisfied with the system, indicating it ensures safety and quality in wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Satisfaction survey within the context of remote iconographic follow-up of wounds in an oncology centre]. Vialoles, N., Fabre, É., Vidal, G., et al.[2020]

Remote patient monitoring software (RPMS) in oncology care significantly improves health-related quality of life and reduces physical symptom burden during cancer treatment, based on a review of nine randomized controlled trials.

The effectiveness of RPMS is enhanced when integrated into routine clinical care, particularly with nurses involved in remote monitoring, indicating that this model can be a valuable addition to standard cancer care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Patient-Reported Outcome Tracking and Health Information Provision via Remote Patient Monitoring Software on Patient Outcomes in Oncology Care: A Systematic Review and Meta-Analysis. Wang, T., Ho, MH., Tong, MCF., et al.[2023]

In a study involving 241 Spanish-speaking patients and 24 health providers, in-person medical interpretation was rated significantly higher by providers and interpreters compared to remote methods, although patients rated all methods equally.

Providers and interpreters preferred video conferencing over telephone interpretation for remote services, highlighting potential concerns about miscommunication in phone interviews due to the lack of visual cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing in-person, video, and telephonic medical interpretation. Locatis, C., Williamson, D., Gould-Kabler, C., et al.[2022]

Remote interpretation via telephone or videoconferencing can lead to shorter waiting times for consultations, making it a more efficient option compared to traditional face-to-face interpretation.

Client and doctor satisfaction levels with remote interpretation are comparable to those of in-person meetings, although interpreters themselves prefer face-to-face interactions, and the costs of remote services are higher but may be justified by the efficiency gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote interpretation in medical encounters: a systematic review. Azarmina, P., Wallace, P.[2018]

In a study involving 1,276 patients at a New York City hospital, those using remote simultaneous medical interpreting (RSMI) reported higher satisfaction with physician communication and felt more respected compared to those using usual interpreting methods.

RSMI also enhanced patients' perception of privacy during medical encounters, suggesting it is a valuable tool for improving experiences for limited-English-proficient patients, although it should not replace language-concordant providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction with different interpreting methods: a randomized controlled trial. Gany, F., Leng, J., Shapiro, E., et al.[2022]

A study involving 236 healthcare employees in Japan found that remote medical interpreting systems were widely used and generally well-received during the COVID-19 pandemic, addressing language barriers in patient care.

However, healthcare professionals expressed concerns about the reliability of connections to interpreting providers, the coordination of remote interpreters, and the overall quality of interpretation, highlighting the need for improved training and support for interpreters in medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of Healthcare Providers towards Remote Medical Interpreting Services in Japan. Saeki, S., Minamitani, K., Iwaoka, F., et al.[2023]

Citations

1.

reporter.nih.gov

reporter.nih.gov/project-details/11164810

rsmi heals - NIH RePORTER

We will compare three types of technology-enabled human-delivered interpreting solutions in a study with limited English proficient breast cancer patients.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06721065

A Study of Language Interpretation Solutions for People ...

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 ...

3.

withpower.com

withpower.com/trial/language-interpretation-solutions-for-breast-cancer-69420

Language Interpretation Solutions for Breast Cancer

Research shows that telehealth, which includes remote interpreting, improves patient access to care, early diagnosis, and treatment, especially in remote areas.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S073839912500134X

Effectiveness of interpreters and other strategies for ...

This is the first systematic review comparing strategies for mitigating language barriers. In healthcare, professional interpreters and shared language were ...

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06721065/a-study-of-language-interpretation-solutions-for-people-with-breast-cancer

A Study of Language Interpretation Solutions for People ...

A Study of Language Interpretation Solutions for People With Breast Cancer ... Remote Consecutive Medical Interpreting/RCMI. Remote Simultaneous ...

6.

mdpi.com

mdpi.com/2306-5354/11/8/846

Remote Symptom Alerts and Patient-Reported Outcomes ...

Symptom surveillance using a remote symptom monitoring (RSM) platform enables the capture and reporting of patient-reported outcomes (PROs) from home.

7.

reporter.nih.gov

reporter.nih.gov/project-details/11194449

Project Details

We will compare RCMI (audio consecutive) (Arm 1), versus RSMI (UN style) (Arm 2) and versus AISMI (AI UN style) (Arm 3) with actors who speak various languages ...