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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

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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 more
Secondary 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 more

Trial 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
875 Previous Clinical Trials
329,736 Total Patients Enrolled
38 Trials studying Prostate Cancer
8,982 Patients Enrolled for Prostate Cancer
University of California, San FranciscoLead Sponsor
2,528 Previous Clinical Trials
15,242,382 Total Patients Enrolled
51 Trials studying Prostate Cancer
16,780 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

Participant Surveys Clinical Trial Eligibility Overview. Trial Name: NCT05396872 — N/A
Prostate Cancer Research Study Groups: Stage 3: Patients, Caregivers using developed GA platform, CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers
Prostate Cancer Clinical Trial 2023: Participant Surveys Highlights & Side Effects. Trial Name: NCT05396872 — N/A
Participant Surveys 2023 Treatment Timeline for Medical Study. Trial Name: NCT05396872 — N/A
~145 spots leftby Jul 2027