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Behavioral Intervention
Audio Recordings for Advanced Prostate Cancer
N/A
Waitlist Available
Led By Daniel Kwon, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current or prior receipt of at least one androgen-signaling inhibitors (ASI) (abiraterone, enzalutamide, apalutamide, or darolutamide), with progression on it
Metastatic castration-resistant prostate cancer (mCRPC) with progression per any Prostate Cancer Working Group 3 (PCWG3) criterion (Prostate-specific antigen (PSA), clinical, or radiographic)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 days
Awards & highlights
Study Summary
This trial is testing a mobile app that lets patients record consultations with their doctors to see if it helps manage their metastatic prostate cancer.
Who is the study for?
This trial is for men with advanced prostate cancer that's resistant to hormone therapy and has never had chemotherapy. They must be able to use an English-only mobile app, have at least one prior treatment with specific drugs, and be planning a discussion about treatment options at UCSF soon. Participants need access to a smartphone or tablet (and a second device for video calls).Check my eligibility
What is being tested?
The study tests a mobile app that records audio during consultations for men with metastatic castrate-resistant prostate cancer. It aims to see if listening back to these recordings helps in making informed decisions regarding their treatment.See study design
What are the potential side effects?
Since the intervention involves using an app rather than medication, traditional side effects are not expected. However, participants may experience emotional or psychological impacts from hearing their medical consultations replayed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have taken hormone therapy for cancer and my cancer got worse on it.
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My prostate cancer has spread and is not responding to hormone therapy.
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I am 18 years old or older.
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I have never had chemotherapy for prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in informed subscale of Decisional Conflict Scale over time
Secondary outcome measures
Mean change in participant-reported anxiety over time
Proportion of approached patients' providers who agree to be recorded
Proportion of enrolled participants who create a recording
+5 moreOther outcome measures
Auto-generated transcript accuracy
Mean change in docetaxel knowledge score over time
Quality of decision support and communication
Trial Design
1Treatment groups
Experimental Treatment
Group I: Consultation audio recordingExperimental Treatment1 Intervention
Instructions on installation and detailed use of chosen application will be provided before an upcoming oncology visit. Research staff will contact the participant and encourage a "practice" recording session. 15-30 minutes prior to the consultation, research staff will send an anonymous text message to the participants' mobile device with a reminder to record the visit. Three days after the consultation, research staff will send an anonymous text reminder message to the participants' mobile device to listen to the recording.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,420 Total Patients Enrolled
51 Trials studying Prostate Cancer
16,982 Patients Enrolled for Prostate Cancer
Conquer Cancer FoundationOTHER
19 Previous Clinical Trials
3,924 Total Patients Enrolled
Daniel Kwon, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
597 Total Patients Enrolled
3 Trials studying Prostate Cancer
570 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to make decisions about joining this trial on my own.I have taken hormone therapy for cancer and my cancer got worse on it.I am 18 years old or older.My doctor approves of me receiving docetaxel chemotherapy at a dose they choose.My prostate cancer has spread and is not responding to hormone therapy.I have never had chemotherapy for prostate cancer.I have a GU oncology appointment at UCSF soon to discuss treatment options.I do not have severe hearing or vision problems that would stop me from doing tasks in the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Consultation audio recording
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant enrollment for this trial?
"Affirmative, according to clinicaltrials.gov the recruitment process of this trial is ongoing. It was initially posted on March 22nd 2022 and recently updated on July 27th 2022. This research project requires 55 participants that will be enrolled at one medical site."
Answered by AI
Is this experiment in search of new participants currently?
"According to the clinicaltrials.gov portal, this experiment is currently looking for volunteers; it was first unveiled on March 22nd 2022 and has been refreshed as recently as July 27th 2022."
Answered by AI
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