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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Participant Surveys

    Other intervention

    Online surveys administered post appointment

  • Mobile app

    Other intervention

    Mobile application installed on mobile device

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, ProvidersExperimental treatment 2 interventions
Group B: Stage 3: Patients, Caregivers using developed GA platformExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

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.

Time frame
Up to 3 years
4

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.

Time frame
Up to 3 years

Secondary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
Up to 6 months
3

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.

Time frame
6 months
4

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

United States Department of Defense

Collaborator