Clinical trial NCT04545697: mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer
Official title: mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer: a Feasibility Trial of a Patient Decision Support Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Prostate Cancer
Keywords: Shared decision-making
Consultation audio recordings
Mobile health
mHealth
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 27
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: 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.

Detailed description: The intervention (provision of instructions on how to install/use the app and how to share the recording with the PSC) will take place 7-60 days before the upcoming oncology consultation. PSC will provide a summary within a week of the consultation.

Primary Objective:

To determine the percentage of enrolled participants who use a clinician-prompted, patient-administered smartphone application to create an audio recording of an outpatient oncology visit.

Secondary Objectives:

1. To determine the percentage of enrolled participants who listen to the audio recording within 1 week after the visit.
2. To determine the percentage of enrolled participants who request and receive a written summary of the consultation from the Patient Support Corps within 1 week after the visit.
3. To determine whether audio recording and summarization change decision-making quality measures.
4. To determine whether audio recording and summarization change provider-reported workload and other outcomes.
5. To determine whether audio recording and summarization change the frequency of follow-up communication between participant and clinic staff.

Participants will be followed via electronic medical record review for 2 weeks after consultation

Eligibility criteria: Inclusion Criteria:

1. Prostate cancer of any histology.
2. Metastatic castrate-resistant Prostate Cancer (mCRPC)
3. Progression per any Prostate Cancer Working Group 3(PCWG3) criterion.
4. Has never received chemotherapy
5. Currently receiving or has previously received any androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide) that was discontinued due to progression
6. 18 years of age or older.
7. Able to read, speak, and write in English.
8. 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.
9. Has access to and ability to use an iPhone (iOS) or Android smartphone.
10. Patient's UCSF oncology provider agrees to be recorded.

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.

Primary outcomes:
measure: Proportion of enrolled participants who utilized the application
timeFrame: Up to 2 weeks after the appointment
Secondary outcomes:
measure: Proportion of enrolled participants who listened to audio recording within 1 week after the visit
timeFrame: Up to 2 weeks after the appointment
measure: Proportion of enrolled participants who obtain written summary of the consultation
timeFrame: Up to 2 weeks after the appointment
measure: Mean participant-reported CollaboRATE scores
timeFrame: Up to 2 weeks after the appointment
measure: Mean score of participant reported Decision Regret Scale (DRS)
timeFrame: Up to 2 weeks after the appointment
measure: Mean change in scores on the Informed subscale of the Decisional Conflict Scale (DCS) from baseline
timeFrame: Baseline and up to 2 weeks after the appointment
measure: Mean perceived change in work burden provider-reported workload and other outcomes
timeFrame: Up to 2 weeks after the appointment
measure: Mean perceived change in provider-patient relationship quality
timeFrame: Up to 2 weeks after the appointment
measure: Mean change in number of participant-initiated telephone call or portal message encounters over time
timeFrame: Baseline and up to 2 weeks after the appointment
Other outcomes:
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: