This clinical trial studies whether a mobile application (app) that enables audio recording of an oncology appointment improves informed treatment decision-making in men with prostate cancer that grows and continues to spread despite the surgical removal of the testes or medical intervention to block androgen production (castration-resistant) and has spread to other parts of the body (metastatic). Recordings allow patients to review, recall, and reflect on information during appointments. Recording with a mobile app during a consultation appointment may lead to a patients having a better understanding of their cancer and better decision-making.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05127850.
PRIMARY OBJECTIVE:
I. To evaluate change in participant informed decision-making after provision of a consultation audio recording application.
SECONDARY OBJECTIVES:
I. To evaluate the percentage of invited participants who enroll. Reasons for not enrolling will be assessed. (Reach)
II. To evaluate the percentage of providers who agree to be recorded. (Adoption)
III. To evaluate the percentage of participants who create an audio recording. (Adoption)
IV. To evaluate the percentage of participants who listen to the audio recording or read its automatically generated transcript. (Adoption)
V. To evaluate the percentage of participants who report receiving instructions on how to record. (Implementation)
VI. To evaluate participant-reported shared decision-making effort.
VII. To evaluate whether participant-reported anxiety changes after provision of a consultation audio recording app.
VIII. 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.
IX. Treatment received.
EXPLORATORY OBJECTIVES:
I. To evaluate whether provision of a consultation audio recording app improves participant-reported knowledge retention of docetaxel.
II. To evaluate accuracy of app auto-generated transcription.
III. To evaluate degree of provider decision support and communication skills.
OUTLINE:
PATIENTS: Patients complete questionnaires and a practice recording session 1-7 days pre-consultation. Patients record the consultation appointment using a mobile app. Patients attend an interview at 1 week post consultation, and complete questionnaires at 1 and 4 weeks post consultation.
PROVIDERS: Participants attend a 15 minute interview within 2 months after the last patient completes the consultation.
After completion of study intervention, patients are followed up for 60 days.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorDaniel H Kwon
