Improving Germline Testing in At-Risk Patients With Prostate Cancer

Study Overview
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Brief Summary
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A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.

Detailed Description
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This is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. Patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. Following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.

Official Title
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IMPRINT: A Pilot Study to Improve Germline Testing in At-Risk Patients With Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Educational intervention.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men, age greater than or equal to 18 years of age. Diagnosis of prostate cancer of any histology. Must meet NCCN guidelines for germline testing Exclusion Criteria: Have had prior germline testing. Have somatic genetic testing that is positive for a possible germline variant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Educational intervention<br>In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator. | Behavioral: Educational intervention.<br>* Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a patient educational program to improve germline genetic testing for eligible patients with prostate cancer. | Accrual rate from study activation | 1 year | 
| Rate of germline genetic testing rate among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines. | Rate of patients agreeing to proceed with germline testing among those approached with the educational intervention. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient baseline knowledge of germline testing and the change in knowledge of germline testing with the educational intervention. | Assessment via baseline and post intervention knowledge questionnaire. | 18 months | 
| Patient baseline attitudes towards germline testing and assess the impact of an education interventional on patient perceptions of germline testing | Assessment via baseline and post intervention questionnaire. | 18 months | 
| Impact of germline testing results on prostate cancer management | Assessment via clinician survey upon receipt of germline testing results. | 18 months | 
| Prevalence of pathogenic germline mutations in patient population | Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Germline testing, Education, Video