Feasibility Study: Educational Genetic Test Video

May 28, 2024 updated by: Virginia Commonwealth University

Pilot Feasibility Study: Educational Genetic Test Video

Assess whether introducing an educational video regarding the benefits, risks, and limitations of genetic testing affects prostate cancer patients' decisional conflict regarding receiving germline genetic testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Prostate cancer patients who have been prescribed germline genetic testing by their provider
  • Understand written and spoken English
  • Have not received germline genetic testing for hereditary cancer risk in the past

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant individuals
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational Video
Educational video about germline genetic testing, which is 7 minutes long
Behavioral: Educational Video
Educational video regarding the benefits, risks, and limitations of genetic testing for hereditary cancer risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the value of presenting patients an educational video regarding the benefits risks, and limitations of genetic testing for hereditary cancer risk.
Time Frame: Day 1
Determine proof-of concept by the results of a patient survey to assess the effect that the video has on decisional conflict. The survey administered post intervention uses a modified decisional conflict scale in a pre then post format. This is a 5 point Likert scale where 1 equals no, 2= probably no, 3= unsure, 4= probably yes, and 5=yes. This format asks participants to imagine their thoughts on the subject before having watched the video, then to clarify their thoughts on the same subjects now that they have watched the video.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Elizabeth Monast, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23-20539
  • HM20028425 (Other Identifier: Virginia Commonwealth University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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