Clinical trial NCT05472714: Educational Video for Genetic Testing
Official title: Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Video Intervention for Newly Diagnosed Families Undergoing Genetic Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genetic Disease
Cancer
Keywords: genetic testing
genetic counseling
germline testing
educational video
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Human Genome Research Institute (NHGRI)
First posted: 2022-07-25
Enrollment: 359
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Comparison between year 1 and year 2 cohorts, with year 2 cohort receiving intervention
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: Inclusion Criteria:

Parents

1. 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)
2. Able to be approached within 1-4 weeks of tumor/normal sequencing
3. Appropriate to approach per oncology team
4. No cognitive impairment limiting ability to complete measures
5. Ability to read and speak English fluently

Adolescent/Young Adult (AYA) probands

1. Child proband receiving germline testing in the Cancer Center at CHOP
2. Ages 12+
3. Able to be approached within 1-4 weeks of tumor/normal sequencing
4. Appropriate to approach per oncology team
5. No cognitive impairment limiting ability to complete measures
6. Ability to read and speak English fluently

Exclusion Criteria:

1) Not meeting any of inclusion criteria.

Primary outcomes:
measure: Knowledge Score - Before Results
timeFrame: up to 4 weeks after testing
Secondary outcomes:
measure: Knowledge Score - After Results
timeFrame: Once, within 6 months after receipt of results
measure: Knowledge Score - all caregivers and probands
timeFrame: Twice, prior to, and within 6 months after receipt of results
measure: Acceptability of use of an informational video on paired tumor/normal testing for participants with a new cancer or other diagnosis
timeFrame: One time, within 6 months after receipt of results
measure: Feasibility of an informational video on paired tumor/normal testing for children and adolescents with a new cancer diagnosis.
timeFrame: One time, within 6 months after receipt of results
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Suzanne MacFarland, MD
role: PRINCIPAL_INVESTIGATOR
References: