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NCT04789018 Clinical Trial

Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology, ENGAGEMENT Study

Prostate Carcinoma Clinical Trial

Official title:
Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology ENGAGEMENT Study (Virtual Genetics Board)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04789018
Other study ID # 20F.936
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 21, 2020
Est. completion date June 24, 2025

Study information
Verified date November 2023
Source Thomas Jefferson University
Contact Veda GIRI, MD
Phone 215-503-7801
Email Veda.Giri@jefferson.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study assesses perceived usefulness of a web-based virtual prostate cancer genetics board for providers across academic, community, and veteran affairs settings to discuss prostate cancer genetics cases, precision treatment, and screening recommendation. Information gained from interviews and surveys of participants taking part in the virtual genetics board may lend insights into perceived usefulness, perceived ease of use, acceptability, self-efficacy, genetics knowledge, and barriers/facilitators to implementation to refine the process.

Description:

PRIMARY OBJECTIVE: I. To assess perceived usefulness of a virtual genetics board. SECONDARY OBJECTIVE: I. To assess acceptability/feasibility, perceived ease of use, self-efficacy for recommendations, genetics knowledge. OUTLINE: Participants complete a survey about genetic knowledge and self efficacy and then attend virtual genetics board. After virtual genetics board meeting, participants complete a second survey about perceived usefulness, ease of use, acceptability, feasibility, self-efficacy and genetic knowledge. Participants may also complete a semi-structured interview after virtual genetics board.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date June 24, 2025
Est. primary completion date June 24, 2025
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: • Non-genetic providers who perform PCA genetic testing for men in their practices (medical oncologists, radiation oncologists, urologists, primary care providers, mid-level providers) Exclusion Criteria: • Non-medical providers

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Educational Intervention
Attend virtual genetics board
• Survey Administration
Complete survey
• Interview
Complete interview

Locations
Country Name City State
United States Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Likert scaled perceived usefulness scores of the virtual genetics board Perceived usefulness will be judged against a benchmark mean score of 5/7. After virtual genetics board
Secondary Means or changes in means of Likert scaled acceptability/feasibility Will be summarized by means, standard deviations, and 95% confidence intervals. Before and after virtual genetics board
Secondary Perceived ease of use Will be summarized by means, standard deviations, and 95% confidence intervals. After virtual genetics board
Secondary Self-efficacy for recommendations Will be summarized by means, standard deviations, and 95% confidence intervals. Before and after virtual genetics board
Secondary Change in mean scores on 17 genetics knowledge test questions Will be summarized by means, standard deviations, and 95% confidence intervals. Baseline up to post-virtual genetics board
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