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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

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