About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible.
If they do not meet any of the inclusion criteria above.
Prior receipt of germline testing.
Prior participation in Stage 1 for germline testing.
Trial design
Sequential
Treatments tested in this trial
Participant Surveys
Other interventionOnline surveys administered post appointment
Mobile app
Other interventionMobile application installed on mobile device
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Mean score on the germline testing knowledge scale (Stage 1)
Proportion of participants with correct responses on where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The proportion of participants who correctly responded to each knowledge item receive a score of 1 for a total score range of 0 - 16. Mean score and 95% CI of the total knowledge scale will be reported.
Mean change in germline testing knowledge score (Stage 3)
The mean change in germline testing knowledge score from baseline to 7 days post appointment will be reported for participants in Stage 3. Participants with correct responses on where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The correct response to each knowledge item receives a score of 1 for a total score range of 0 - 16. Mean change in score and 95% CI of the total knowledge scale will be reported.
Proportion of participants with correct responses on germline testing knowledge scale
The germline testing knowledge scale is a 16 item survey where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The proportion of participants who correctly responded to each knowledge item and 95% CI for each knowledge item will be reported.
Mean score on the somatic testing knowledge scale
The somatic testing knowledge scale is a 17-item survey where participants response with an True, false, or don't know to each item addressing information they have received regarding personalized cancer therapy and molecular testing (target therapy). The proportion of participants who correctly responded to each knowledge item receive a score of 1 for a total score range of 0 - 17. Mean score and 95% CI of the total knowledge scale will be reported.
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
United States Department of Defense
Collaborator