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mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer: a Feasibility Trial of a Patient Decision Support Intervention
Patients surviving with advanced prostate cancer frequently encounter time points in their disease course that require choosing among multiple options regarding systemic therapy. Interventions to improve shared decision-making through patient support measures such as question listing, and audio recording and summarizing of consultations have been shown to improve patient-reported measures of decision making quality, e.g. decreased decisional conflict and regret. However, the feasibility of consultation recording and summarizing with mobile health (mHealth) technology on patient-owned smartphones is unknown. The investigators will conduct a single-arm trial to determine feasibility and acceptability of a clinician-prompted, patient administered smartphone audio recording application and a service to summarize the recordings (Patient Support Corps or PSC), in improving decision-making quality among patients with chemotherapy-naive, progressive, metastatic castration-resistant prostate cancer (mCRPC). This trial will inform the design and conduct of a larger trial evaluating broader scale implementation of this intervention.
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: 1. To determine the percentage of enrolled participants who listen to the audio recording within 1 week after the visit. 2. 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. 3. To determine whether audio recording and summarization change decision-making quality measures. 4. To determine whether audio recording and summarization change provider-reported workload and other outcomes. 5. 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
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
University of California, San Francisco
San Francisco, California, United States
Start Date
September 18, 2020
Primary Completion Date
February 28, 2021
Completion Date
February 28, 2021
Last Updated
June 1, 2021
27
ACTUAL participants
Medcorder
OTHER
Lead Sponsor
University of California, San Francisco
NCT07181161
NCT06616597
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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