Educational Video for Genetic Testing

NCT05472714 | Completed Results

• 2 other identifiers: 21-019152R21HG011912
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

Brief Summary

Develop and evaluate the acceptability, feasibility, and preliminary efficacy of an informational video on paired tumor/normal testing for children and adolescents with a new diagnosis of cancer, tumors or other diagnosis.

Conditions

Cancer; Genetic Disease

Keywords

genetic testing; genetic counseling; germline testing; educational video

Outcome Measures

Primary Outcomes (1)

• Percentage of Correct Items on Knowledge Questionnaire - Before Results

  The primary outcome is the percentage of correct items on a genetic knowledge survey that was developed for this study, measured at baseline and before receipt of genetic test results. Participants evaluated included the primary caregivers, secondary caregivers and probands aged 12+. Total scores were generated by summarizing total number of correct responses and generating a percentage. The Genetic Knowledge measure included 12 true/false questions. Higher scores indicate higher genetic knowledge.

  Up to 4 weeks after testing

Secondary Outcomes (4)

• Percentage of Correct Items on Knowledge Questionnaire - After Results

  Up to 6 months post-genetic test result

• Acceptability of Use of an Informational Video on Paired Tumor/Normal Testing for Participants With a New Cancer or Other Diagnosis

  One time, within 6 months after receipt of results

• Intervention Feasibility - Technical Error

  One time, within 6 months after receipt of results

• Intervention Feasibility - Days to Receive Intervention

  One time, within 6 months after receipt of results

Other Outcomes (2)

• Satisfaction With Decision Scale (SDS) - Before Results

  Up to 4 weeks after testing

• Impact of Events Scale (IES) - Before Results

  Up to 4 weeks after testing

Study Arms (2)

Without Video

NO INTERVENTION

In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider based education.

With Video

EXPERIMENTAL

In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider based education and an educational video.

Other: Educational Video

Interventions

Educational Video OTHER

Investigators will develop an informational video to be presented within one week of diagnosis of a tumor to those referred for tumor normal paired genetic testing.

With Video

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents
• Parent or Legal Guardian of a patient with a new diagnosis of cancer, tumor, or other diagnosis referred for tumor/normal sequencing (proband) in the Cancer Center at the Children's Hospital of Philadelphia (CHOP)
• Able to be approached within 1-4 weeks of tumor/normal sequencing
• Appropriate to approach per oncology team
• No cognitive impairment limiting ability to complete measures
• Ability to read and speak English fluently
• Adolescent/Young Adult (AYA) probands
• Child proband receiving germline testing in the Cancer Center at CHOP
• Ages 12+
• Able to be approached within 1-4 weeks of tumor/normal sequencing
• Appropriate to approach per oncology team
• No cognitive impairment limiting ability to complete measures
• Ability to read and speak English fluently

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institutes of Health (NIH): collaborator
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Genetic Diseases, Inborn; Neoplasms

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Suzanne MacFarland MD
• Organization: Children's Hospital of Philadelphia

macfarlands@chop.edu

2153006428

Study Officials

• Suzanne MacFarland, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison between year 1 and year 2 cohorts, with year 2 cohort receiving intervention

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 25, 2022
• Study Start: September 10, 2021
• Primary Completion: March 22, 2025
• Study Completion: March 22, 2025
• Last Updated: June 16, 2026
• Results First Posted: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request
• Access Criteria: Upon request

Locations

US (1)