Clinical trial NCT05958082: Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients with High-Risk Prostate Cancer
Official title: Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients with High-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: genetic testing
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Testing rate
timeFrame: 24 months
Secondary outcomes:
measure: Baseline knowledge per "Patient Survey on Germline Testing in Prostate Cancer" questionnaire
timeFrame: Day 1, before intervention
measure: Post-intervention knowledge per "Patient Post-Education Patient Survey" questionnaire
timeFrame: Day 1, after intervention
measure: Clinician attitudes per "Post Results Clinician Questionnaire"
timeFrame: 24 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Cancer Pavilion
state: Michigan
Study officials:
References: