Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Daniel Kwon, MD
Photo of Daniel Kwon
Daniel Kwon

Description

Summary

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 progressive metastatic prostate cancer. This trial will inform the design and conduct of a larger trial evaluating broader scale implementation of this intervention.

Official Title

mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer: a Feasibility Trial of a Patient Decision Support Intervention

Details

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

Keywords

Metastatic Prostate Cancer Shared decision-making Consultation audio recordings Mobile health mHealth Prostatic Neoplasms Medcorder

Eligibility

You can join if…

Open to males ages 18 years and up

  1. Prostate cancer of any histology.
  2. Metastatic castrate resistant prostate cancer (mCRPC) with progression on 1st-line androgen signaling inhibitors (ASI) (i.e. abiraterone, enzalutamide, apalutamide) that was started in the metastatic hormone-sensitive setting per any Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criterion.
  3. 18 years of age or older.
  4. Able to read, speak, and write in English.
  5. Has an upcoming genitourinary (GU) medical oncology appointment (in-person or Zoom video visit) within 7-60 days of enrollment.
  6. Has access to and ability to use an iOS or Android smartphone.
  7. Patient's oncology provider agrees to be recorded.

You CAN'T join if...

  1. Lack of decision-making capacity to provide consent to this trial.
  2. Uncorrectable hearing or visual impairment hindering the ability to perform necessary tasks in the trial.
  3. Any neurocognitive or psychiatric disorder hindering the ability to perform necessary tasks in the trial.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Daniel Kwon, MD
    Clinical Fellow, Medicine. Authored (or co-authored) 9 research publications. Research interests: Genitourinary cancer · Shared decision-making · Quality of life · Outcomes research · Biomarkers.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04545697
Study Type
Interventional
Last Updated