Clinical trial NCT05127850: MENCORE-2: Audio Recordings to Improve Decision-making in Advanced Prostate Cancer
Official title: Mhealth ElectroNic COnsultation REcording (MENCORE-2): an Implementation Trial to Improve Informed Treatment Decision-making in Men With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Metastatic Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Keywords: Consultation audio recordings
Shared decision-making
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
First posted: 2021-11-19
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Mean change in docetaxel knowledge score over time
timeFrame: Up to 2 weeks
measure: Mean change in informed subscale of Decisional Conflict Scale over time
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Proportion of invited participants who consent to the study
timeFrame: 1 day
measure: Proportion of approached patients' providers who agree to be recorded
timeFrame: 1 day
measure: Mean change in participant-reported anxiety over time
timeFrame: Up to 2 weeks
measure: Proportion of enrolled participants who create a recording
timeFrame: Up to 2 weeks
measure: Proportion of enrolled participants who listen to the recording
timeFrame: Up to 2 weeks
measure: Proportion of enrolled participants who report they received both mailed/emailed instructions to install/use the app
timeFrame: Up to 2 weeks
measure: Proportion of participants who report high shared decision-making effort
timeFrame: Up to 2 weeks
measure: Proportion of patients who received docetaxel
timeFrame: Up to 30 days
measure: Proportion of patients who received docetaxel
timeFrame: Up to 60 days
Other outcomes:
measure: Mean change in docetaxel knowledge score over time
timeFrame: Up to 28 days
measure: Auto-generated transcript accuracy
timeFrame: Up to 60 days
measure: Quality of decision support and communication
timeFrame: Up to 60 days
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Daniel Kwon, MD
role: PRINCIPAL_INVESTIGATOR
References: