mHealth ElectroNic COnsultation REcording (mENCORE) in Advanced Prostate Cancer

University of California San Francisco (UCSF)

Status: Completed

Conditions: Metastatic Prostate Cancer

Treatments: Other: Medcorder

Study type: Interventional

Funder types: Other

Identifiers

NCT04545697

NCI-2020-07023 (Registry Identifier)

20554

Details and patient eligibility

About

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.

Full 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

Enrollment: 27 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Patient Decision Support

Experimental group

Description:

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.

Treatment:

Other: Medcorder