NCT05127850

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

November 8, 2021

Last Update Submit

May 7, 2024

Conditions

Prostate CancerMetastatic Prostate CancerMetastatic Castration-resistant Prostate Cancer

Keywords

Consultation audio recordingsShared decision-making

Outcome Measures

Primary Outcomes (2)

  • Mean change in docetaxel knowledge score over time

    Change in docetaxel knowledge score is measured by participant report of knowledge using a docetaxel knowledge instrument, measured at baseline and 7 days post-appointment. The instrument was developed based on facts that patients and providers deem are important when making a treatment decision that includes docetaxel as an option for mCRPC (e.g., disease, prognosis, risks, benefits, alternatives). The score is standardized, ranging from from 0 to 100, with higher scores indicating a greater knowledge in docetaxel. Mean change in scores will be reported, as well as standard deviations.

    Up to 2 weeks

  • Mean change in informed subscale of Decisional Conflict Scale over time

    The informed subscale of the Decisional Conflict Scale is comprised of 3 items given a score value of 0 = 'strongly agree to 4 = 'strongly disagree'. The items are summed, divided by 3, and then multiplied by 25. Scores range from 0 (feels extremely informed) to 100 (feels extremely uninformed).

    Up to 2 weeks

Secondary Outcomes (9)

  • Proportion of invited participants who consent to the study

    1 day

  • Proportion of approached patients' providers who agree to be recorded

    1 day

  • Mean change in participant-reported anxiety over time

    Up to 2 weeks

  • Proportion of enrolled participants who create a recording

    Up to 2 weeks

  • Proportion of enrolled participants who listen to the recording

    Up to 2 weeks

  • +4 more secondary outcomes

Other Outcomes (3)

  • Mean change in docetaxel knowledge score over time

    Up to 28 days

  • Auto-generated transcript accuracy

    Up to 60 days

  • Quality of decision support and communication

    Up to 60 days

Study Arms (1)

Consultation audio recording

EXPERIMENTAL

Instructions on installation and detailed use of chosen application will be provided before an upcoming oncology visit. Research staff will contact the participant and encourage a "practice" recording session. 15-30 minutes prior to the consultation, research staff will send an anonymous text message to the participants' mobile device with a reminder to record the visit. Three days after the consultation, research staff will send an anonymous text reminder message to the participants' mobile device to listen to the recording.

Behavioral: Consultation audio recording app

Interventions

Consultation audio recording appBEHAVIORAL

Smartphone or tablet mobile application which allows for voice recording

Also known as: Voice Recording app, Mobile voice recording app, Smartphone voice recording app, Tablet voice recording app
Consultation audio recording

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic castration-resistant prostate cancer (mCRPC) with progression per any Prostate Cancer Working Group 3 (PCWG3) criterion (Prostate-specific antigen (PSA), clinical, or radiographic)
  • Has never received any chemotherapy for prostate cancer.
  • Current or prior receipt of at least one androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide), with progression on it.
  • Eligible for docetaxel chemotherapy at any dose level (treating provider's discretion).
  • 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).
  • years of age or older.
  • Able to read, speak, and write in English (the application is in English only)
  • Has access to and ability to use an iOS or Android smartphone or tablet.
  • 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.
  • Patient's provider of the upcoming appointment in #5 agrees to be recorded.
  • \. UCSF GU medical oncology providers (medical doctor (MD), nurse practitioner (NP), or physician's assistant (PA)), regardless of whether their patient was enrolled

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • Kwon DH, Trihy L, Darvish N, Hearst E, Sumra S, Borno HT, Bose R, Chou J, de Kouchkovsky I, Desai A, Ekstrand B, Friedlander T, Kaur G, Koshkin VS, Nesheiwat S, Sepucha K, Small EJ, Aggarwal RR, Belkora J. Patients Can Administer Mobile Audio Recordings to Increase Knowledge in Advanced Prostate Cancer. Cancer Med. 2024 Nov;13(22):e70433. doi: 10.1002/cam4.70433.

    PMID: 39569542DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Daniel Kwon, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 19, 2021

Study Start

March 22, 2022

Primary Completion

February 16, 2024

Study Completion

April 30, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)