Breast CancerNCT02726360
Physician Use of Non-English Language Skills in Cancer Care
An observational study of Breast Cancer and Colon Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The purpose of this study is to test a method for analyzing interactions between patients and doctors, the Roter Interaction Analysis System (RIAS). The RIAS measures the quality of communication between patients and their cancer doctors. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colon Cancer, Lung Cancer
- What is being tested?
- survey and Audio record
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 71 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Dec 2015to 21 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll all treating physicians of participating sites who are likely to treat LEP Spanish-speaking patients. All patient recruitment will be done by bilingual research staff who are consenting professionals with (when necessary) a volunteer affiliation with the collaborating study site.
Who may be able to join
- is a English or Spanish-speaking patient
- between the ages of 21-80 years old
- has a new diagnosis of any type of cancer (diagnosed within the past 4 months), or has a recurrence of either breast, colon or lung cancer (recurrence diagnosed within the past 4 months)
- scheduled to have surgery or begin chemotherapy and/or radiation therapy within the next 2 months
- Oncology clinician Inclusion:
- provides care to LEP patients
- has MD, DO, RN, NP or PA degree
- is between the ages of 21-80
Who cannot join
- is unable to provide informed consent in either English or Spanish
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Ralph Lauren Center for Cancer Care and Prevention
New York, New York
Elmhurst Hospital Center
Queens, New York, 11373
Lincoln Medical Center
The Bronx, New York
About this study
The purpose of this study is to test a method for analyzing interactions between patients and doctors, the Roter Interaction Analysis System (RIAS). The RIAS measures the quality of communication between patients and their cancer doctors.
- Conditions
- Breast Cancer, Colon Cancer, Lung Cancer
- Being tested
- survey, Audio record
- Keywords
- Communication, 15-316, Physician, Use, Non-English, Language Skills
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyBehavioural
Also called ILR Scale
The ILR Scale, a non-English language proficiency self-assessment.
Audio recordBehavioural
Audio record the initial visits between patients and their treating physician
| Study group | Role | What they receive |
|---|---|---|
| Oncology physician | Physicians (MD or DO) in the oncology departments of participating hospitals will complete a survey. Non-English language proficiency will be assessed by self-assessment using Interagency Language Roundtable (ILR) scale, which the PI has previously used. The physician survey is collected among treating physicians of patients enrolled to MSK IRB approved protocols 12-099 and 12-223 at some of the participating hospitals. For physicians who already completed this survey as part of participation in protocol 12-099 or 12-223, data will be extracted from the respective study's REDCap database. Receives: Behavioral: survey; Behavioral: Audio record | |
| patients | Audio record the initial visits between patients and their treating physician. Analyze 48 patient-physician dyad recordings using the Roter Interaction Analysis System (RIAS). Receives: Behavioral: Audio record |
What is being measured
The primary outcome is the main question the study is designed to answer.
study-specific coding structure
using the RIAS in cancer care across English and Spanish languages will be assessed by evaluating whether this existing, validated coding system 'works' across a language barrier.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start14 Dec 2015
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Edward-Elmhurst Health System, Johns Hopkins University, Lincoln Medical and Mental Health Center, Queens Cancer Center of Queens Hospital
- Responsible party
- Sponsor
- Investigators
- Lisa Diamond, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726360
- Sponsor's protocol ID
- 15-316
- Status last verified
- Aug 2023
- First submitted
- 15 Mar 2016
- Last updated
- 23 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Use of Non-English Language Skills in Cancer Care
- ClinicalTrials.gov ID
- NCT02726360
- Acronym / sponsor ID
- 15-316
- Conditions
- Breast Cancer, Colon Cancer, Lung Cancer
- Keywords
- Communication, 15-316, Physician, Use, Non-English, Language Skills
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Edward-Elmhurst Health System, Johns Hopkins University, Lincoln Medical and Mental Health Center, Queens Cancer Center of Queens Hospital
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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 purpose of this study is to test a method for analyzing interactions between patients and doctors, the Roter Interaction Analysis System (RIAS). The RIAS measures the quality of communication between patients and their cancer doctors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncology physician | – | Behavioral: survey, Behavioral: Audio recordPhysicians (MD or DO) in the oncology departments of participating hospitals will complete a survey. Non-English language proficiency will be assessed by self-assessment using Interagency Language Roundtable (ILR) scale, which the PI has previously used. The physician survey is collected among treating physicians of patients enrolled to MSK IRB approved protocols 12-099 and 12-223 at some of the participating hospitals. For physicians who already completed this survey as part of participation in protocol 12-099 or 12-223, data will be extracted from the respective study's REDCap database. |
| patients | – | Behavioral: Audio recordAudio record the initial visits between patients and their treating physician. Analyze 48 patient-physician dyad recordings using the Roter Interaction Analysis System (RIAS). |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll all treating physicians of participating sites who are likely to treat LEP Spanish-speaking patients. All patient recruitment will be done by bilingual research staff who are consenting professionals with (when necessary) a volunteer affiliation with the collaborating study site.
Key inclusion criteria (8 listed)
- is a English or Spanish-speaking patient
- between the ages of 21-80 years old
- has a new diagnosis of any type of cancer (diagnosed within the past 4 months), or has a recurrence of either breast, colon or lung cancer (recurrence diagnosed within the past 4 months)
- scheduled to have surgery or begin chemotherapy and/or radiation therapy within the next 2 months
- provides care to LEP patients
Key exclusion criteria (1 listed)
- is unable to provide informed consent in either English or Spanish
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 |
|---|---|---|
| surveyAlso: ILR ScaleThe ILR Scale, a non-English language proficiency self-assessment. | Behavioural | Oncology physician |
| Audio recordAudio record the initial visits between patients and their treating physician | Behavioural | Oncology physician, patients |
Primary outcome
study-specific coding structure
Time frame: 2 years
using the RIAS in cancer care across English and Spanish languages will be assessed by evaluating whether this existing, validated coding system 'works' across a language barrier.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Lisa Diamond, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colon Cancer, run by Memorial Sloan Kettering Cancer Center at 5 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study-specific coding structure (time frame: 2 years). 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 23 Aug 2023.