Educational Video for Genetic Testing

Cancer Clinical Trial

Official title:

Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Video Intervention for Newly Diagnosed Families Undergoing Genetic Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472714
• Other study ID #: 21-019152
• Secondary ID: R21HG011912
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Children's Hospital of Philadelphia
• Contact: Suzanne MacFarland, MD
• Phone: (267) 425-1919
• Email: macfarlands[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 356
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Genetic Disease
• Genetic Diseases, Inborn

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knowledge Score - After 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.	Once, within 6 months after receipt of results
Secondary	Knowledge Score - all caregivers and probands	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.	Twice, prior to, and within 6 months after receipt of results
Secondary	Acceptability of use of an informational video on paired tumor/normal testing for participants with a new cancer or other diagnosis	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.	One time, within 6 months after receipt of results
Secondary	Feasibility of an informational video on paired tumor/normal testing for children and adolescents with a new cancer diagnosis.	Feasibility will be assessed with absence of technical difficulties of video delivery and timeliness of delivery of video after recommendation for testing.	One time, within 6 months after receipt of results