Educational Video for Genetic Testing

Children's Hospital of Philadelphia355 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

355

Conditions

Genetic Disease Cancer

Interventions

Educational VideoOTHER

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

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 4 weeks after testing

Secondary Outcomes

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.

Time frame: Once, within 6 months after receipt of results

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.

Time frame: 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

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.

Time frame: 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.

Feasibility will be assessed with absence of technical difficulties of video delivery and timeliness of delivery of video after recommendation for testing.

Time frame: One time, within 6 months after receipt of results

Data from ClinicalTrials.gov

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