Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients With High-Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients With High-Risk Prostate Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05958082
• Other study ID #: 16491
• Secondary ID: HFH-23-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: Henry Ford Health System
• Contact: Clara Hwang, MD
• Phone: 313-556-8830
• Email: chwang2[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Educational video
The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer.

Locations

Country	Name	City	State
United States	Henry Ford Cancer Pavilion	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testing rate	percentage of patients who undergo genetic testing after completing the education session	24 months
Secondary	Baseline knowledge per "Patient Survey on Germline Testing in Prostate Cancer" questionnaire	Pre-Intervention Patient Questionnaire: The pre-intervention patient questionnaire is a brief 16-item investigator-developed knowledge and attitude scale applicable to this population. It was developed through an expert panel to determine if participants are able to recall key core components about multigene panel testing and capture attitudes about genetic testing. This survey is estimated to take 10 minutes to complete.	Day 1, before intervention
Secondary	Post-intervention knowledge per "Patient Post-Education Patient Survey" questionnaire	Post-Intervention Patient Questionnaire: The post-intervention patient questionnaire is a brief 24-item investigator-developed knowledge and attitude scale applicable to this population. It includes the same 14 knowledge and attitude items from the pre-intervention survey to assess impact of the educational intervention. It was developed through an expert panel to determine if participants are able to recall key core components about multi-gene panel testing and capture attitudes about genetic testing. There is also a 10-item scale to capture satisfaction with educational intervention. This survey is estimated to take 10 minutes to complete.	Day 1, after intervention
Secondary	Clinician attitudes per "Post Results Clinician Questionnaire"	Post-Results Clinician Questionnaire: The post-result clinician questionnaire is a brief 6-item investigator-developed scale to assess whether the genetic testing results altered clinical practice for any given patient including change in disease monitoring, change in recommended treatment, referral to genetic counseling and other parameters. This survey is estimated to take 5 minutes to complete.	24 months