MENCORE-2: Audio Recordings to Improve Decision-making in Advanced Prostate Cancer

University of California San Francisco (UCSF)

Status: Completed

Conditions: Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Prostate Cancer

Treatments: Behavioral: Consultation audio recording app

Study type: Interventional

Funder types: Other

Identifiers

NCT05127850

NCI-2021-11595 (Registry Identifier)

21559

Details and patient eligibility

About

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.

Full description

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 an application prior to the first physician visit and then followed-up 7 days, 28 days and 60 days after their physician encounter.

Enrollment: 51 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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).

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Consultation audio recording

Experimental group

Description:

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.

Treatment:

Behavioral: Consultation audio recording app