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Decision-Making Support Tools for Prostate Cancer
N/A
Recruiting
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
Documentation of locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.
Age 18 years or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will study how to best support patients in making decisions about precision oncology treatments.
Who is the study for?
This trial is for Veterans aged 18 or older with advanced prostate cancer, including those with pelvic lymph node-positive, metastatic, or castration-resistant types. Participants must speak and understand English, be able to follow the study procedures throughout its duration, and provide informed consent. Those involved in a patient's care can also join if they consent verbally.Check my eligibility
What is being tested?
The study aims to improve how Veterans make decisions about precision oncology treatments for advanced prostate cancer. It involves using participant surveys and a mobile app to gather data on decision-making processes regarding genetic testing and targeted therapies.See study design
What are the potential side effects?
Since this trial focuses on decision-making rather than medical interventions like drugs or surgeries, there are no direct physical side effects from participating. However, discussing sensitive health information could potentially cause emotional or psychological discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is advanced, spread to lymph nodes, or resistant to hormone therapy.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean score on the Decisional Conflict Scale (DCS) (Stage 1)
Proportion of participants enrolled (Stage 3)
Proportion of participants providing reason for not enrolling (Stage 3)
+1 moreSecondary outcome measures
Mean Brief Decision Support Analysis Tool (DSAT-10) scores
Mean change in germline testing knowledge score (Stage 3)
Mean change in score on the Decisional Conflict Scale (DCS) (Stage 3)
+18 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Stage 3: Patients, Caregivers using developed GA platformExperimental Treatment2 Interventions
About 14 days prior to scheduled germline testing appointment, patients and caregivers call or meet with a coach to select decision aid GA platform preference delivery (online, print, or both online and print), review the GA online platform, and possibly undergo consultation and training for audio recording of the scheduled appointment. Patients and caregivers attend the scheduled germline testing appointment on day 1. Patients complete surveys and patients and caregivers may complete an interview on study. Providers participate in focus groups and complete surveys on study.
Group II: CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, ProvidersExperimental Treatment2 Interventions
Patient participants will be instructed to install a mobile app to record their medical appointment, which research staff will use to analyze patient-provider communication. All participants will undergo semi-structured interviews and/or focus groups. Post appointment follow-up with surveys and assessments regarding knowledge of disease information, quality of life, and other measures will be administered after the provider-patient appointment.
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
865 Previous Clinical Trials
327,449 Total Patients Enrolled
38 Trials studying Prostate Cancer
8,954 Patients Enrolled for Prostate Cancer
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,305 Total Patients Enrolled
51 Trials studying Prostate Cancer
16,783 Patients Enrolled for Prostate Cancer
Daniel Kwon, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
398 Total Patients Enrolled
3 Trials studying Prostate Cancer
371 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an upcoming appointment to discuss genetic or tumor testing and targeted therapy.I understand and can follow the study's procedures.My prostate cancer is advanced, spread to lymph nodes, or resistant to hormone therapy.You can read and understand a document that explains the study, and you are willing to sign it.You are able to give your agreement by speaking.I have someone who helps with my care and they're willing to join interviews.You can speak and understand English.I meet the initial requirements to be considered for the study.I am 18 years old or older.You can speak, read, and understand English.
Research Study Groups:
This trial has the following groups:- Group 1: CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers
- Group 2: Stage 3: Patients, Caregivers using developed GA platform
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 maximum number of patients that can be a part of this clinical trial?
"That is correct. The clinical trial, which was posted on May 12th, 2022, is currently looking for 117 patients to enroll at 1 location."
Answered by AI
Are there any available vacancies for participants in this experiment?
"That is correct, the online information does show that the trial is still recruiting patients. The posting date was May 12th, 2022 and the most recent update was June 22nd, 2022. There is a total need for 117 individuals across one location."
Answered by AI
What is the goal of this research?
"The primary outcome of this trial, which will be measured over a 6 months time frame is to Proportion of participants with a total score of >37.5 on the DCS. Secondary outcomes include Proportion of participants with correct responses on germline testing knowledge scale which is defined as The germline testing knowledge scale is a 16 item survey where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The proportion of participants who correctly responded to each knowledge item and 95% CI for each knowledge item will be reported., Proportion of providers who responded to yes for pre-test germline"
Answered by AI
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