Feasibility Study: Educational Genetic Test Video

NCT06166758 | Completed DMC

• 2 other identifiers: MCC-23-20539HM20028425
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Education

Keywords

Genetic testing education

Outcome Measures

Primary Outcomes (1)

• Assess the value of presenting patients an educational video regarding the benefits risks, and limitations of genetic testing for hereditary cancer risk.

  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

Study Arms (1)

Educational Video

EXPERIMENTAL

Educational video about germline genetic testing, which is 7 minutes long

Behavioral: Educational Video

Interventions

Educational Video BEHAVIORAL

Educational video regarding the benefits, risks, and limitations of genetic testing for hereditary cancer risk.

Educational Video

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Elizabeth Monast

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 12, 2023
• Study Start: December 14, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)