Decision Support Tool to Enhance Germline Genetic Testing for Patients With Prostate Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This clinical trial identifies factors associated with completing genetic testing, aids in the development of a decision support tool, and tests how well the decision support tool works to enhance germline genetic testing in patients with prostate cancer. Germline genetic testing is a guideline-recommended standard of care for many patients with prostate cancer. Completing genetic testing can enable the use of targeted therapies, offers access to novel clinical trials, provides valuable information, and can help identify at risk family members. The decision support tool may educate patients and assist in the decision to engage with germline genetic testing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed prostate cancer patients receiving care at Lyndon B. Johnson (LBJ) Hospital

Were recommended for germline genetic testing by their oncology provider

Can provide informed consent

Can communicate in English or Spanish

Disqualifiers

Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition

Trial design

Design model

Sequential

Treatments tested in this trial

  • Behavioral Intervention

    Behavioral

    View decision support tool

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Genetic Counseling

    Other intervention

    Meet with genetic counselor

  • Genetic Testing

    Other intervention

    Undergo standard of care genetic testing

  • Interview

    Other intervention

    Complete qualitative interview

  • Interview

    Other intervention

    Complete cognitive interview

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Group 1 (Qualitative interview)Other 2 interventions
Group B: Group 2 (Draft decision support tool, cognitive interview)Other 2 interventions
Group C: Group 3 (Decision tool)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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