Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-01-01 @ 2:39 AM
Study NCT ID:
NCT05127850
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2021-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MENCORE-2: Audio Recordings to Improve Decision-making in Advanced Prostate Cancer
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Mhealth ElectroNic COnsultation REcording (MENCORE-2): an Implementation Trial to Improve Informed Treatment Decision-making in Men With Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-11595 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View |