Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05396872
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Participant Surveys — OTHER
    Online surveys administered post appointment
  • Mobile app — OTHER
    Mobile application installed on mobile device

Study Details

This clinical trial explores and implements methods to improve informed decision making (IDM) regarding precision oncology tests amongst veterans with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Precision oncology, the use of germline genetic testing and tumor-based molecular assays to inform cancer care, has become an important aspect of evidence-based care for men with advanced prostate cancer. Veterans with metastatic castrate-resistant prostate cancer may not be carrying out IDM due to unmet decisional needs. An informed decision is a choice based on complete and accurate information. The information gained from this study will help researchers develop a decision support intervention (DSI) and implement the intervention. A DSI may serve as a valuable tool to reduce ongoing racial disparities in genetic testing and encourage enrollment to precision oncology trials.

Key Dates

Start date
May 12, 2022
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers
    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.
  • Experimental: Stage 3: Patients, Caregivers using developed GA platform
    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.

Primary Outcome Measure

Mean score on the Decisional Conflict Scale (DCS) (Stage 1) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Veterans Affairs Medical CenterSan FranciscoCalifornia94121
UCSF Genitourinary Medical Oncology Recruitment
[email protected]
877-827-3222
[email protected]
Daniel Kwon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
San Francisco Veterans Affairs Medical Center· San Francisco, CA

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