Educational Video for Genetic Testing
Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Video Intervention for Newly Diagnosed Families Undergoing Genetic Testing
2 other identifiers
interventional
355
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2021
CompletedFirst Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2025
CompletedNovember 19, 2025
November 1, 2025
3.5 years
July 18, 2022
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knowledge Score - Before Results
The primary outcome is the primary caregiver's knowledge score measured before receipt of genetic results. Knowledge score is a 12-point true/false questionnaire. Higher scores indicate higher genetic knowledge.
up to 4 weeks after testing
Secondary Outcomes (4)
Knowledge Score - After Results
Once, within 6 months after receipt of results
Knowledge Score - all caregivers and probands
Twice, prior to, and within 6 months after receipt of results
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
Feasibility of an informational video on paired tumor/normal testing for children and adolescents with a new cancer diagnosis.
One time, within 6 months after receipt of results
Study Arms (2)
Without Video
NO INTERVENTIONIn 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
EXPERIMENTALIn 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.
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne MacFarland, MD
Children's Hospital of Philadelphia
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
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
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Upon request
- Access Criteria
- Upon request
Investigators are committed to making all data, protocols, tools, and materials available to the scientific community, in compliance with Children's Hospital of Philadelphia policies and NIH "Sharing Data and Resources" statement, NIH Grants Policy Statement, and the NIH Office of Extramural Research, Division of Extramural Inventions \& Technology Resources (DEITR) Intellectual Property Policy. This includes sharing of protocols freely with collaborators and sharing of data through peer-reviewed publication and presentation in scientific meetings. All members of the research team will comply with the NIH policy on sharing data by protecting the privacy and rights of human subjects involved in the research at all times. All members of the research team with comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its accompanying regulations.