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

640 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Remote Consecutive Medical Interpreting and related methods for breast cancer?

Research shows that telehealth, which includes remote interpreting, improves patient access to care, early diagnosis, and treatment, especially in remote areas. This can lead to better patient satisfaction and outcomes, as seen in various healthcare settings. ^{1 2 3 4 5}

Is remote medical interpreting safe for use in healthcare settings?

The research suggests that remote medical interpreting is an acceptable and accurate alternative to traditional face-to-face methods, with no specific safety concerns reported. Satisfaction levels among patients and doctors are comparable to in-person interpreting, although interpreters prefer face-to-face interactions. ^{6 7 8 9 10}

How is the treatment 'Language Interpretation Solutions for Breast Cancer' different from other treatments for breast cancer?

This treatment is unique because it focuses on providing remote language interpretation services to improve communication between patients and healthcare providers, rather than directly treating the cancer itself. It aims to enhance understanding and decision-making for patients who may face language barriers during their cancer treatment. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2022]

2. Netherlands 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Access to Care: Using eHealth to Limit Location-Based Barriers for Patients With Cancer. [2021]

4. United States 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. [2023]

5. France pubmed.ncbi.nlm.nih.gov

[Satisfaction survey within the context of remote iconographic follow-up of wounds in an oncology centre]. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Eliminating language barriers for non-English-speaking patients. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Comparing in-person, video, and telephonic medical interpretation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Remote interpretation in medical encounters: a systematic review. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Patient satisfaction with different interpreting methods: a randomized controlled trial. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Perspectives of Healthcare Providers towards Remote Medical Interpreting Services in Japan. [2023]

11. Brazil 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. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Preoperative breast MRI for locoregional staging. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Breast Imaging Second Opinions Impact Surgical Management. [2022]

14. United States 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? [2020]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical findings and outcomes of MRI staging of breast cancer in a diverse population. [2020]