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.
PRIMARY OBJECTIVES: I. Identify patient, provider, and health system factors contributing to the completion of recommended germline testing for men with prostate cancer. II. Develop a decision support tool for patients tailored to the cultural and socioeconomic context of the local community. III. Conduct a pilot intervention trial to evaluate a point-of-care decision support tool in a public safety net hospital in Harris County, Texas. SECONDARY OBJECTIVES: I. Assess the feasibility of point-of-care decision support tool in a public safety net hospital in Harris County, Texas. II. Assess the change in completion of germline genetic testing with utilization of the decision support tool. OUTLINE: At each stage of the proposed research, patients are recruited to 1 of 3 groups. Groups 1 and 2 are observational and group 3 is a pilot interventional trial. GROUP 1: Patients complete a qualitative interview that informs the development of the decision support tool. GROUP 2: Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study. GROUP 3: Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
108
View decision support tool
Undergo blood sample collection
Ancillary studies
Meet with genetic counselor
Undergo standard of care genetic testing
Complete qualitative interview
Complete cognitive interview
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSafety 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.