NCT05127850

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

Mhealth ElectroNic COnsultation REcording (MENCORE-2): an Implementation Trial to Improve Informed Treatment Decision-making in Men With Advanced Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Metastatic Prostate Cancer
• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Consultation audio recording app	Smartphone or tablet mobile application which allows for voice recording

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-02-16
• Completion: 2024-04-30
• First posted: 2021-11-19
• Last updated: 2024-05-08

Locations

1 site across 1 country: United States