Prostate Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral Intervention
View decision support tool
PROCEDUREBiospecimen Collection
Undergo blood sample collection
OTHERElectronic Health Record Review
Ancillary studies
OTHERGenetic Counseling
Meet with genetic counselor
OTHERGenetic Testing
Undergo standard of care genetic testing
OTHERInterview
Complete qualitative interview
OTHERSurvey Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDebanjan Pain
M.D. Anderson Cancer Center
Outcome results
None listed