NCT05396872 · University of California, San Francisco
Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer
What this study is about
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).
View original scientific description
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.
Interventions
OTHER
Participant Surveys
Online surveys administered post appointment
OTHER
Mobile app
Mobile application installed on mobile device
Primary outcome measures
Mean score on the Decisional Conflict Scale (DCS) (Stage 1)
Time frame: 6 months
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.
Proportion of participants with a total score of >37.5 on the DCS (Stage 1)
Time frame: 6 months
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.
Proportion of participants enrolled (Stage 3)
Time frame: Up to 3 years
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.
Proportion of participants providing reason for not enrolling (Stage 3)
Time frame: Up to 3 years
The proportion of invited participants who do not consent to the study will have the reason for not joining recorded and totaled.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Able to provide consent via email. Stage 2: Inclusion Criteria: Patient participants:
- Participated in Stage 1.
- Completed either germline or tumor testing for prostate cancer.
- Able to understand study procedures and to comply with them for the entire length of the study. Caregiver-participants:
- Participated in Stage 1.
- Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver). SFVAHCS Provider-participants:
- Participated in Stage 1.
- Meets one of the two following criteria:
- Physician specializing in medical oncology (MD, post-first year clinical fellows allowed) who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.
- Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study. Non-SFVAHCS provider-participants:
- Meets one of the three following criteria:
- Principal investigator of a Precision Oncology Program for Cancer of the Prostate (POPCaP) site.
- Physician specializing in medical oncology who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.
- Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study. Note: For Non-SFVAHCS providers, fellows are not eligible.
- Able to understand study procedures and to comply with them for the entire length of the study. Stage 3: Inclusion Criteria 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 high-risk localized, very high-risk localized, 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. 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 interview.
- Able to provide verbal consent.
- Able to speak and understand English. Provider-participants
- SFVAHCS physician (MD) trained in medical oncology or undergoing training as a clinical fellow.
- Has discussed germline testing for prostate cancer with an SFVAHCS patient within the past year of being contacted about the study, or plans to discuss germline testing for prostate cancer with an SFVAHCS patient.
- Able to provide verbal consent. Stage 1:
Exclusion criteria
- 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
- If they do not meet any of the inclusion criteria above. Stage 2: Exclusion Criteria 1\. Participants who do not meet the inclusion criteria above. Stage 3: Exclusion Criteria Patient-participants:
- Prior receipt of germline testing.
- Prior participation in Stage 1 for germline testing. Caregiver and Provider-Participants 1\. If they do not meet any of the inclusion criteria above.
Where
- San Francisco, California
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 9, 2026 · Source of record for eligibility and locations