Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT05127850
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.
Study:
NCT05127850
Study Brief:
Protocol Section:
NCT05127850