CancerNCT02969031
Improving Communication Between Cancer Patients & Oncologists
A study testing Enhanced SCOPE training and Standard Communication training in people with Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The overarching goal of this project is to improve communication between oncologists and their patients by ensuring that the patient's voice is heard in the medical encounter. Thus, the hope is to improve the experience for patients living with cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Enhanced SCOPE training and Standard Communication training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All American Board of Internal Medicine (ABIM) Board certified oncologists practicing in the U. S. and enrolled in Maintenance of Certification.
- Have a study-compatible smart phone.
- Eligible patients will have metastatic cancer.
- At least 18 years of age.
- Speak and read English.
- Receive oncology care from an enrolled oncologist.
Who cannot join
- Dana Farber Cancer Institute oncologists and oncologists who do not speak English to their patients.
- Patients who do not speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Improving Communication Between Cancer Patients and Oncologists Using Patient Feedback on Actual Conversations and the ABIM Maintenance of Certification Program
The overarching goal of this project is to improve communication between oncologists and their patients by ensuring that the patient's voice is heard in the medical encounter. Thus, the hope is to improve the experience for patients living with cancer. The investigators seek to accomplish this goal by providing oncologists communication skills training that includes feedback on their own audio-recorded conversations. The feedback will come from two sources: 1) Professional research assistant coders who will identify objective learning opportunities based on specific coding criteria and 2) Trained patient reviewers who will listen to the recordings and offer their own, subjective feedback at key moments in the encounters.
Read the detailed description
The primary objective of the Enhanced SCOPE program is to teach oncologists to recognize the role of emotion in discussions with cancer patients, to increase their self-efficacy for addressing affective concerns, and to provide them with the skills for doing so. Oncologists are most likely to achieve competency in these areas when, in addition to didactic training, they can also observe their own conversation and receive feedback on their interactions. The Enhanced SCOPE program itself is an online web application that can be viewed from any computer with internet connectivity. The investigators will be conducting a randomized controlled trial to test the impact on patient satisfaction and medical visit quality of a communication skills teaching intervention for oncologists that is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process. Oncologists who choose to enroll in this pilot Practice Improvement Module (PIM) will complete a baseline questionnaire, send out satisfaction surveys to a sample of their patients, and then audio record (using a smartphone application) eight clinic visits with eight different patients. Oncologists who are assigned to the control arm will receive the results of the patient surveys and be asked to conduct a quality improvement activity that responds to the feedback (the current "standard" communication PIM). Oncologists assigned to the intervention arm will receive the survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web based interactive program. The feedback will come from two sources: 1) Professional research assistant coders who will identify objective learning opportunities based on specific coding criteria (e.g., empathic opportunities, use of open-ended questions) and 2) Trained patient reviewers who will listen to the recordings and offer their own, subjective feedback at key moments in the encounters. These patient reviewers will be drawn from our stakeholder partners and are active patient advocates. They will be treated as members of the research team, paid for the reviews, and are not patients of the study physicians. One month after reviewing their feedback, oncologists in both arms will audio record another eight encounters and send out satisfaction surveys to a new sample of patients.
- Conditions
- Cancer
- Being tested
- Enhanced SCOPE training, Standard Communication training
- Keywords
- communication
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced SCOPE trainingBehavioural
Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.
Standard Communication trainingBehavioural
Standard Communication training
| Study group | Role | What they receive |
|---|---|---|
| Enhanced SCOPE training | Experimental | Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program. Receives: Behavioral: Enhanced SCOPE training |
| Standard Communication training | Active comparator | Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current "standard" communication PIM). Receives: Behavioral: Standard Communication training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider to Patient Communication Score
The score measures the construct of patient's perception of attentive response by the medical oncologist during recalled office encounters over 12 months. Patients completed the Clinician Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS©) Version 1.0 questionnaire via computer or phone Interactive Voice Response (IVR) system.The Provider to Patient Communication Score:(1) Provider explained things in a way that was easy to understand (2) Provider listened carefully to patient (3) Provider showed respect for what patient had to say (4) Provider spent enough time with patient. Coded as 1 (Yes, definitely), 2 (Yes, somewhat), 3 (No), or 4 (I prefer not to answer).Obtained aggregate score ((1) to (3) above), calculated avg. of the scores to each question. Avgs. modeled with linear mixed-effect model. Analyzed data in both cases where a) missing responses are dropped from data and b) missing responses are kept in dataset. Lower score indicates more desirable outcome.
Measured: 6 months
Secondary outcomes (1)
Empathic Response to Patient Expressions of Negative Emotions
What does the outcome measure? The outcome measures the construct of a physician's skill at providing appropriate empathic responses to patient's expressions of emotional concerns. The measure is the ratio of the number of empathic responses to the total empathic opportunities that occur during a provider-patient encounter.
How is the outcome measured? The provider-patient encounters are audio recorded. Trained listeners review, score and code the physician responses from the audio-recorded conversations. This code indicates an empathic opportunity. Behaviors that represent appropriate empathic responses are also coded.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start14 Feb 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Board of Internal Medicine, Duke University, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, James A. Tulsky, Dana-Farber Cancer Institute
- Investigators
- James A. Tulsky, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969031
- Sponsor's protocol ID
- 16-099
- Status last verified
- Dec 2019
- First submitted
- 16 Nov 2016
- Last updated
- 3 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Communication Between Cancer Patients and Oncologists Using Patient Feedback on Actual Conversations and the ABIM Maintenance of Certification Program
- ClinicalTrials.gov ID
- NCT02969031
- Acronym / sponsor ID
- 16-099
- Conditions
- Cancer
- Keywords
- communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Board of Internal Medicine, Duke University, Patient-Centered Outcomes Research Institute
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Posted 3 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this project is to improve communication between oncologists and their patients by ensuring that the patient's voice is heard in the medical encounter. Thus, the hope is to improve the experience for patients living with cancer. The investigators seek to accomplish this goal by providing oncologists communication skills training that includes feedback on their own audio-recorded conversations. The feedback will come from two sources: 1) Professional research assistant coders who will identify objective learning opportunities based on specific coding criteria and 2) Trained patient reviewers who will listen to the recordings and offer their own, subjective feedback at key moments in the encounters.
Detailed description
The primary objective of the Enhanced SCOPE program is to teach oncologists to recognize the role of emotion in discussions with cancer patients, to increase their self-efficacy for addressing affective concerns, and to provide them with the skills for doing so. Oncologists are most likely to achieve competency in these areas when, in addition to didactic training, they can also observe their own conversation and receive feedback on their interactions. The Enhanced SCOPE program itself is an online web application that can be viewed from any computer with internet connectivity. The investigators will be conducting a randomized controlled trial to test the impact on patient satisfaction and medical visit quality of a communication skills teaching intervention for oncologists that is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process. Oncologists who choose to enroll in this pilot Practice Improvement Module (PIM) will complete a baseline questionnaire, send out satisfaction surveys to a sample of their patients, and then audio record (using a smartphone application) eight clinic visits with eight different patients. Oncologists who are assigned to the control arm will receive the results of the patient surveys and be asked to conduct a quality improvement activity that responds to the feedback (the current "standard" communication PIM). Oncologists assigned to the intervention arm will receive the survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web based interactive program. The feedback will come from two sources: 1) Professional research assistant coders who will identify objective learning opportunities based on specific coding criteria (e.g., empathic opportunities, use of open-ended questions) and 2) Trained patient reviewers who will listen to the recordings and offer their own, subjective feedback at key moments in the encounters. These patient reviewers will be drawn from our stakeholder partners and are active patient advocates. They will be treated as members of the research team, paid for the reviews, and are not patients of the study physicians. One month after reviewing their feedback, oncologists in both arms will audio record another eight encounters and send out satisfaction surveys to a new sample of patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced SCOPE training | Experimental | Behavioral: Enhanced SCOPE trainingComplete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program. |
| Standard Communication training | Active comparator | Behavioral: Standard Communication trainingComplete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current "standard" communication PIM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All American Board of Internal Medicine (ABIM) Board certified oncologists practicing in the U. S. and enrolled in Maintenance of Certification.
- Have a study-compatible smart phone.
- Eligible patients will have metastatic cancer.
- At least 18 years of age.
- Speak and read English.
Key exclusion criteria (2 listed)
- Dana Farber Cancer Institute oncologists and oncologists who do not speak English to their patients.
- Patients who do not speak English.
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 |
|---|---|---|
| Enhanced SCOPE trainingIntervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process. | Behavioural | Enhanced SCOPE training |
| Standard Communication trainingStandard Communication training | Behavioural | Standard Communication training |
Primary outcome
Provider to Patient Communication Score
Time frame: 6 months
The score measures the construct of patient's perception of attentive response by the medical oncologist during recalled office encounters over 12 months. Patients completed the Clinician Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS©) Version 1.0 questionnaire via computer or phone Interactive Voice Response (IVR) system.The Provider to Patient Communication Score:(1) Provider explained things in a way that was easy to understand (2) Provider listened carefully to patient (3) Provider showed respect for what patient had to say (4) Provider spent enough time with patient. Coded as 1 (Yes, definitely), 2 (Yes, somewhat), 3 (No), or 4 (I prefer not to answer).Obtained aggregate score ((1) to (3) above), calculated avg. of the scores to each question. Avgs. modeled with linear mixed-effect model. Analyzed data in both cases where a) missing responses are dropped from data and b) missing responses are kept in dataset. Lower score indicates more desirable outcome.
1 secondary outcome
Empathic Response to Patient Expressions of Negative Emotions
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Patient-Centered Outcomes Research Institute (PCORI) Research Award ListingLink provided by the sponsor.
- Dana Farber Cancer Institute (DFCI), Department of Psychosocial Oncology and Palliative Care (POPC) Listing of Current Research and PCORI AwardLink provided by the sponsor.
- Vital Talk is a non-profit whose mission is to nurture healthier connections between patients and clinicians. We are using Vital Talk intellectual property (e.g., REMAP) for the interventionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
James A. Tulsky, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced SCOPE training and Standard Communication training in people with Cancer, run by Dana-Farber Cancer Institute at 1 site 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 6 inclusion and 2 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 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 3 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Provider to Patient Communication Score (time frame: 6 months). 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 3 Jan 2020.