Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05958082 | NOT YET RECRUITING | Prostate Cancer

Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients with High-Risk Prostate Cancer
Sponsor:

Henry Ford Health System

Information provided by (Responsible Party):

Clara Hwang

Brief Summary:

This is a pilot study to improve rates of germline genetic testing for black patients with aggressive prostate cancer as recommended by the updated guidelines by the National Cancer Comprehensive Network (NCCN) in 2018. In this study, consented patients will undergo a low-risk intervention of an educational session with a trained staff member on germline testing in prostate cancer and, if agreeable, subsequent germline cancer genetic testing via a commercial lab test.

Condition or disease

Prostate Cancer

Intervention/treatment

Educational video

Phase

NA

Detailed Description:

This is a prospective, single-arm, quality improvement initiative for the use of a standardized educational intervention on germline testing in black patients with prostate cancer to improve the rates of germline genetic testing among those recommended for testing. Patients who consent to the study will undergo a one-on-one in-person education session regarding the rationale and the benefits/risks of germline testing. The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer. At the start of the session, the patient will be given a short questionnaire to assess their understanding about germline and genetic testing, along with a Family History questionnaire. Following the educational intervention, the patient will be asked to complete a short patient education and satisfaction questionnaire. If a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay. Upon a patient deciding to pursue testing, testing will consist of a prostate cancer germline panel with a commercially available blood or saliva-based assay. Upon receipt of the results, the coordinator will alert the patient's clinician, who will then share the results with the patient either in clinic or by phone. If the results show a pathogenic germline mutation, the patient will be referred to see Henry Ford Health genetics clinic for consultation with a genetics counselor. If a patient pursues genetic testing, following receipt of results, the patient's clinicians will be asked to complete a short survey on to assess how the results of germline testing affected the patient's current and future management.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients with High-Risk Prostate Cancer
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Men, age greater than or equal to 18 years of age.
  • 2. Men who racially identify as black or multiracial including black
  • 3. Diagnosis of prostate cancer of any histology.
  • 4. Must meet NCCN guidelines for germline testing
  • 1. Men with very low, low or intermediate risk prostate per NCCN guidelines with a positive family history or intraductal histology. Family history here is considered significant if the patient has
    • * a first degree relative with prostate cancer or more than one first/second degree relative with prostate cancer, or
    • * ≥3 cancers on same side of family, especially diagnoses ≤50 years of age: bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (but not clinically localized Grade Group 1), small bowel, or urothelial cancer
    • 2. Men with high-risk, very-high risk (per NCCN definitions of risk groups), lymph node positive, or metastatic prostate cancer independent of family history of histology.
    Exclusion Criteria
    • 1. Have had prior germline testing.
    • 2. Have somatic genetic testing that is positive for a possible germline variant.
Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients with High-Risk Prostate Cancer

Location Details

NCT05958082

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, road cancer

Henry Ford Cancer Pavilion

Detroit, road cancer, United States, 48202