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
Headshot of Daniel Kwon
Daniel Kwon

Description

Summary

This is a single-arm hybrid implementation trial of men with metastatic castrate-resistant prostate cancer (mCRPC) involving a clinician-prompted, patient-administered mobile app tailored for consultation audio recordings.

Official Title

Mhealth ElectroNic COnsultation REcording (MENCORE-2): an Implementation Trial to Improve Informed Treatment Decision-making in Men With Advanced Prostate Cancer

Details

PRIMARY OBJECTIVE: 1. To evaluate change in participant informed decision-making after provision of a consultation audio recording application. SECONDARY OBJECTIVES: 1. Reach. To evaluate the percentage of invited participants who enroll. Reasons for not enrolling will be assessed. 2. Adoption. To evaluate the percentage of providers who agree to be recorded. 3. Adoption. To evaluate the percentage of participants who create an audio recording. 4. Adoption. To evaluate the percentage of participants who listen to the audio recording or read its automatically generated transcript. 5. Implementation. To evaluate the percentage of participants who report receiving instructions on how to record. 6. To evaluate participant-reported shared decision-making effort. 7. To evaluate whether participant-reported anxiety changes after provision of a consultation audio recording app. 8. To evaluate barriers, facilitators, and experiences of recording app use, particularly in the context of treatment decision-making by conducting participant interviews, provider surveys, and interviews with providers. 9. Treatment received. EXPLORATORY OBJECTIVES: 1. To evaluate whether provision of a consultation audio recording app improves participant-reported knowledge retention of docetaxel. 2. To evaluate accuracy of app auto-generated transcription. 3. To evaluate degree of provider decision support and communication skills. Participants are set up with the application prior to their first physician visit and then followed-up 7 days, 28 days and 60 days after their physician encounter.

Keywords

Prostate Cancer Metastatic Prostate Cancer Metastatic Castration-resistant Prostate Cancer Consultation audio recordings Share decision-making Prostatic Neoplasms Consultation audio recording app Consultation audio recording

Eligibility

You can join if…

Open to males ages 18 years and up

  1. Metastatic castration-resistant prostate cancer (mCRPC) with progression per any Prostate Cancer Working Group 3 (PCWG3) criterion (Prostate-specific antigen (PSA), clinical, or radiographic)
  2. Has never received any chemotherapy for prostate cancer.
  3. Current or prior receipt of at least one androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide), with progression on it.
  4. Eligible for docetaxel chemotherapy at any dose level (treating provider's discretion).
  5. Has an upcoming genitourinary (GU) medical oncology appointment (in-person, telephone, or Zoom video visit) at University of California, San Francisco (UCSF) within 7-60 days of enrollment, during which next-line treatment options are anticipated to be discussed (treating provider's discretion).
  6. 18 years of age or older.
  7. Able to read, speak, and write in English (the application is in English only)
  8. Has access to and ability to use an iOS or Android smartphone or tablet.
  9. For video visits only: has access to and ability to use a second device (e.g., desktop, laptop, smartphone, tablet, etc.) that will run a Zoom video visit.
  10. . Patient's provider of the upcoming appointment in #5 agrees to be recorded.

Inclusion criteria (provider participants):

  1. UCSF GU medical oncology providers (medical doctor (MD), nurse practitioner (NP), or physician's assistant (PA)), regardless of whether their patient was enrolled

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.
  4. Prior participation in Mobile Health ElectroNic COnsultation REcording (mENCORE) (participants have already received the intervention).

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Daniel Kwon, MD
    Assistant Professor, Medicine. Authored (or co-authored) 16 research publications. Research interests: Genitourinary cancer · Shared decision-making · Hospital based oncology · Survivorship · Outcomes research · Biomarkers.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05127850
Study Type
Interventional
Last Updated