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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met