Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-06571 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2025-1272 | Other Identifier | M D Anderson Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Qualitative interview) | Other | Patients complete a qualitative interview that informs the development of the decision support tool. |
|
| Group 2 (Draft decision support tool, cognitive interview) | Other | 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 (Decision tool) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | View decision support tool |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion; an average of 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Debanjan Pain | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
|
| Electronic Health Record Review | Other | Ancillary studies |
|
| Genetic Counseling | Other | Meet with genetic counselor |
|
| Genetic Testing | Other | Undergo standard of care genetic testing |
|
|
| Interview | Other | Complete qualitative interview |
|
| Interview | Other | Complete cognitive interview |
|
| Survey Administration | Other | Ancillary studies |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D013048 | Specimen Handling |
| D005817 | Genetic Counseling |
| D005820 | Genetic Testing |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D005821 | Genetic Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided