Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer
A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer
2 other identifiers
interventional
250
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started May 2022
Longer than P75 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2022
CompletedFirst Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 9, 2026
March 1, 2026
5.2 years
May 25, 2022
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Mean score on the Decisional Conflict Scale (DCS) (Stage 1)
The Decisional Conflict Scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scoring and interpretation Items are given a score value ranging from 0 = 'strongly disagree' to 4 = 'strongly agree'. Total Scores are a sum of the scores of the 16 items and are scaled by divided by 16 and then multiplied by 25 for a total scale score range from 0 \[extremely high decisional conflict\] to 100 \[no decisional conflict\]. Mean score and 95% confidence interval (CI) of the total DCS as well as the 4 subscales will be calculated.
6 months
Proportion of participants with a total score of >37.5 on the DCS (Stage 1)
Participants who completed the DCS will be divided by their total score into those who scored \>37.5 or not. The proportion of participants with a total score of \> 37.5 will be reported.
6 months
Proportion of participants enrolled (Stage 3)
The proportion of invited participants who consent to the study compared to the total number of participants approached will be reported as measured by study entry.
Up to 3 years
Proportion of participants providing reason for not enrolling (Stage 3)
The proportion of invited participants who do not consent to the study will have the reason for not joining recorded and totaled.
Up to 3 years
Secondary Outcomes (21)
Mean score on the germline testing knowledge scale (Stage 1)
6 months
Mean change in germline testing knowledge score (Stage 3)
Up to 6 months
Proportion of participants with correct responses on germline testing knowledge scale
6 months
Mean score on the somatic testing knowledge scale
6 months
Proportion of participants with correct responses on the somatic testing knowledge scale
6 months
- +16 more secondary outcomes
Study Arms (2)
CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers
EXPERIMENTALPatient 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.
Stage 3: Patients, Caregivers using developed GA platform
EXPERIMENTALAbout 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.
Interventions
Online surveys administered post appointment
Mobile application installed on mobile device
Eligibility Criteria
You may qualify if:
- Patient-participants:
- Age 18 years or older.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to understand a written informed consent document and willing to sign it.
- Able to speak, read, and understand English.
- Documentation of locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.
- Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing, somatic tumor testing, or targeted therapy.
- Caregiver-participants:
- Age 18 years or older.
- Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interviews.
- Able to provide verbal consent.
- Able to speak and understand English.
- Provider-participants:
- Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed).
- Has discussed germline testing, somatic testing, or targeted therapy for an San Francisco Veteran Health Care System (SFVAHCS) patient with locally advanced or metastatic prostate cancer (as defined above) within the past 90 days of being contacted about the study.
- +36 more criteria
You may not qualify if:
- Patient-participants:
- For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible.
- Caregiver and Provider-Participants
- Patient-participants:
- Prior receipt of germline testing.
- Prior participation in Stage 1 for germline testing.
- Caregiver and Provider-Participants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Kwon, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2022
First Posted
May 31, 2022
Study Start
May 12, 2022
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share