Educational Video for Genetic Testing
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
As over 15% of pediatric cancers are associated with a cancer predisposition, it is increasingly becoming standard of care for children with cancer, as well as those with suspected hereditary risk, to be evaluated for germline cancer predisposition. Unfortunately, the increase in pediatric genetic testing has exceeded the pace of research establishing best practices to optimize delivery of care for patients undergoing testing and their families. Tumor/normal genetic testing (testing of both tumor tissue and a paired normal sample) at time of cancer diagnosis or relapse is now widespread in pediatric oncology to improve cancer diagnostics, prognostics, and treatment; this testing also has potential to uncover underlying cancer predisposition syndromes with lifelong implications. Disseminating information at the time of cancer diagnosis is difficult, and is best done by a provider with expertise in cancer genetics. Thus, Investigators will develop an informational video for use prior to tumor/normal genetic testing to augment genetic counseling resources to support patients and families.
In this study, Investigators will 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. Investigators will use a non randomized trial whereby a convenience sample of patients/families will be recruited to be controls in Year 1, followed by a convenience sample that will be allocated the video intervention In Year 2. To evaluate the impact of the video intervention, Investigators will compare assessments of two cohorts- an unexposed (no video intervention, Year 1) and exposed (video intervention, Year 2).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Without Video In year 1, we will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider based education. |
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| Experimental: With Video In year 2, we 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
We 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.
|
Outcome Measures
Primary Outcome Measures
- Knowledge Score - Before Results [up to 4 weeks after testing]
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.
Secondary Outcome Measures
- Knowledge Score - After Results [Once, within 6 months after receipt of results]
The primary caregiver's knowledge score measured after receipt of genetic results, which is the same knowledge score measured before receipt of results. Knowledge score is a 12-point true/false questionnaire.
- Knowledge Score - all caregivers and probands [Twice, prior to, and within 6 months after receipt of results]
Another secondary analysis will include data from all caregivers' (primary and secondary) and probands' (over 12 years of age) knowledge scores. The knowledge score is a 12-point true/false questionnaire.
- 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]
Acceptability will be assessed using a questionnaire including a satisfaction with decision scale, a 6 question decision satisfaction measure, an impact of events scale for cancer-specific distress, a 15 item questionnaire, and a multidimensional impact of cancer risk assessment, a 6 item questionnaire.
- 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]
Feasibility will be assessed with absence of technical difficulties of video delivery and timeliness of delivery of video after recommendation for testing.
Eligibility Criteria
Criteria
Inclusion Criteria:
Parents
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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)
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Able to be approached within 1-4 weeks of tumor/normal sequencing
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Appropriate to approach per oncology team
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No cognitive impairment limiting ability to complete measures
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Ability to read and speak English fluently
Adolescent/Young Adult (AYA) probands
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Child proband receiving germline testing in the Cancer Center at CHOP
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Ages 12+
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Able to be approached within 1-4 weeks of tumor/normal sequencing
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Appropriate to approach per oncology team
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No cognitive impairment limiting ability to complete measures
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Ability to read and speak English fluently
Exclusion Criteria:
- Not meeting any of inclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Children's Hospital of Philadelphia
- National Institutes of Health (NIH)
- National Human Genome Research Institute (NHGRI)
Investigators
- Principal Investigator: Suzanne MacFarland, MD, Children's Hospital of Philadelphia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB 21-019152
- R21HG011912