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Trial Title:
Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients with High-Risk Prostate Cancer
NCT ID:
NCT05958082
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
genetic testing
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Educational video
Description:
The educational intervention will occur with a clinical research coordinator who will be
trained to educate on germline testing in prostate cancer.
Arm group label:
Educational intervention
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henry Ford Cancer Pavilion
Address:
City:
Detroit
Zip:
48202
Country:
United States
Contact:
Last name:
Clara Hwang, MD
Phone:
313-556-8830
Email:
chwang2@hfhs.org
Start date:
December 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Henry Ford Health System
Agency class:
Other
Source:
Henry Ford Health System
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05958082
