Improving Germline Testing in At-Risk Patients With Prostate Cancer

University of California, San Diego50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Educational intervention.BEHAVIORAL

Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men, age greater than or equal to 18 years of age. 2. Diagnosis of prostate cancer of any histology. 3. Must meet NCCN guidelines for germline testing Exclusion Criteria: 1. Have had prior germline testing. 2. Have somatic genetic testing that is positive for a possible germline variant.

Locations (1)

University of California San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention.

Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.

Time frame: Within 1 year

Secondary Outcomes

Patient Baseline Knowledge of Germline Testing

Assessment via baseline knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge

Time frame: Baseline

Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing

Assessment via post intervention questionnaire. Survey Title: Patient Post-Education Patient Survey Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge

Time frame: Within 18 months

Number of Participants With Pathogenic Germline Mutations

Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.

Time frame: within 18 months

Patient Knowledge of Germline Testing After the Educational Intervention.

Assessment via post intervention knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge

Time frame: within 18 months

Data from ClinicalTrials.gov

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