- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545697
mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer (mENCORE)
mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer: a Feasibility Trial of a Patient Decision Support Intervention
Study Overview
Detailed Description
The intervention (provision of instructions on how to install/use the app and how to share the recording with the PSC) will take place 7-60 days before the upcoming oncology consultation. PSC will provide a summary within a week of the consultation.
Primary Objective:
To determine the percentage of enrolled participants who use a clinician-prompted, patient-administered smartphone application to create an audio recording of an outpatient oncology visit.
Secondary Objectives:
- To determine the percentage of enrolled participants who listen to the audio recording within 1 week after the visit.
- To determine the percentage of enrolled participants who request and receive a written summary of the consultation from the Patient Support Corps within 1 week after the visit.
- To determine whether audio recording and summarization change decision-making quality measures.
- To determine whether audio recording and summarization change provider-reported workload and other outcomes.
- To determine whether audio recording and summarization change the frequency of follow-up communication between participant and clinic staff.
Participants will be followed via electronic medical record review for 2 weeks after consultation
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Prostate cancer of any histology.
- Metastatic castrate-resistant Prostate Cancer (mCRPC)
- Progression per any Prostate Cancer Working Group 3(PCWG3) criterion.
- Has never received chemotherapy
- Currently receiving or has previously received any androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide) that was discontinued due to progression
- 18 years of age or older.
- Able to read, speak, and write in English.
- Has an upcoming genitourinary (GU) medical oncology appointment (in-person or Zoom video visit) at University of California, San Francisco (UCSF) within 7-60 days of enrollment.
- Has access to and ability to use an iPhone (iOS) or Android smartphone.
- Patient's UCSF oncology provider agrees to be recorded.
Exclusion Criteria:
- Lack of decision-making capacity to provide consent to this trial.
- Uncorrectable hearing or visual impairment hindering the ability to perform necessary tasks in the trial.
- Any neurocognitive or psychiatric disorder hindering the ability to perform necessary tasks in the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Patient Decision Support
Instructions will be provided for installation and use of a smartphone recording app 7-60 days before an oncology consultation.
Participants will share the recording with the Patient Support Corps (PSC), who will summarize the recording, send it to the participant's oncologist for review, then return an annotated summary to the participant within a week of the consultation.
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Medcorder is a smartphone app that is HIPAA compliant for the use of on patient recordings of consults with healthcare providers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of enrolled participants who utilized the application
Time Frame: Up to 2 weeks after the appointment
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Proportion of enrolled participants who create a complete audio consultation recording of the appointment using the application, measured by application metrics, at 1 week post-consultation along with 95% confidence interval will be reported.
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Up to 2 weeks after the appointment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of enrolled participants who listened to audio recording within 1 week after the visit
Time Frame: Up to 2 weeks after the appointment
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Proportion of enrolled participants who listen to the recording, measured by participant-reported survey at 1 week post-consultation along with 95% confidence interval will be reported.
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Up to 2 weeks after the appointment
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Proportion of enrolled participants who obtain written summary of the consultation
Time Frame: Up to 2 weeks after the appointment
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Proportion of enrolled participants who request and receive a written summary of the consultation from the Patient Support Corps (PSC) within 1 week after the visit along with 95% confidence interval will be reported.
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Up to 2 weeks after the appointment
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Mean participant-reported CollaboRATE scores
Time Frame: Up to 2 weeks after the appointment
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The CollaboRATE is a 3-item questionnaire developed to measure shared decision making in reference to the most recent appointment the participant may have had with the oncologist. The questions are as follows: (i) How much effort was made to help you understand your health issues? (ii) How much effort was made to listen to what matters most to you about your health is-sues? (iii) How much effort was made to include what matters most to you in choosing what to do next? Each response ranges from a score of 0-9, with a response of 0 = "No effort was made" and 9="Every effort was made". Higher total scores represent more shared decision making. |
Up to 2 weeks after the appointment
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Mean score of participant reported Decision Regret Scale (DRS)
Time Frame: Up to 2 weeks after the appointment
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The DRS is a 5-item questionnaire where participants are asked to reflect on a past decision, and then asked to indicated the extent to which they agree or disagree with the statement in the regret scale by indication a number from 1 (Strongly) to 5 (Strongly Disagree) that best indicated their level of agreement.
Scores are converted to a 0-100 scale with a lower scores indicating less regret.
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Up to 2 weeks after the appointment
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Mean change in scores on the Informed subscale of the Decisional Conflict Scale (DCS) from baseline
Time Frame: Baseline and up to 2 weeks after the appointment
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The "Informed" subscale of the DCS consists of 3 items which measure the degree that the participant feel informed, with scores that range from 0 (strongly agree) to 4 (Strongly disagree).
Scores are summed and then converted to a scale of 0-100, with lower indicating a greater degree of feeling informed.
For analyzing changes in DCS information subscale, a two-tailed paired sample t-test will be used to determine whether the mean difference between pre- and post-consultation survey scores is 0 or not.
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Baseline and up to 2 weeks after the appointment
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Mean perceived change in work burden provider-reported workload and other outcomes
Time Frame: Up to 2 weeks after the appointment
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The change in work burden will be determined using a provider-reported workload survey to determine whether audio recording produced a change in work burden at 1 week post-consultation among providers with enrolled participants.
There are 5 possible responses: "Decreased work", "No Change", "A little more work", "Some more work", and "A lot more work".
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Up to 2 weeks after the appointment
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Mean perceived change in provider-patient relationship quality
Time Frame: Up to 2 weeks after the appointment
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The change in provider-patient relationship quality will be determined using a provider-reported survey to determine whether audio recording produced a change in the provider patient relationship at 1 week post-consultation among providers with enrolled participants.
There are 5 possible responses: "Negatively", "Somewhat Negatively", "No change", "Somewhat Positively", and "Positively".
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Up to 2 weeks after the appointment
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Mean change in number of participant-initiated telephone call or portal message encounters over time
Time Frame: Baseline and up to 2 weeks after the appointment
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Changes in the frequency of follow-up communication between participant and clinic staff in the electronic health record from baseline (2 weeks pre-consultation to consultation) to post-consultation (consultation to 2 weeks post-consultation).
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Baseline and up to 2 weeks after the appointment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20554
- NCI-2020-07023 (REGISTRY: NCI Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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