mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer

NCT04545697 | Completed DMC

• 2 other identifiers: 20554NCI-2020-07023
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Metastatic Prostate Cancer

Keywords

Shared decision-making; Consultation audio recordings; Mobile health; mHealth

Outcome Measures

Primary Outcomes (1)

• Proportion of enrolled participants who utilized the application

  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.

  Up to 2 weeks after the appointment

Secondary Outcomes (8)

• Proportion of enrolled participants who listened to audio recording within 1 week after the visit

  Up to 2 weeks after the appointment

• Proportion of enrolled participants who obtain written summary of the consultation

  Up to 2 weeks after the appointment

• Mean participant-reported CollaboRATE scores

  Up to 2 weeks after the appointment

• Mean score of participant reported Decision Regret Scale (DRS)

  Up to 2 weeks after the appointment

• Mean change in scores on the Informed subscale of the Decisional Conflict Scale (DCS) from baseline

  Baseline and up to 2 weeks after the appointment

Study Arms (1)

Patient Decision Support

EXPERIMENTAL

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.

Other: Medcorder

Interventions

Medcorder OTHER

Medcorder is a smartphone app that is HIPAA compliant for the use of on patient recordings of consults with healthcare providers.

Patient Decision Support

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male 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: September 4, 2020
• First Posted: September 11, 2020
• Study Start: September 18, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)