Educational Video for Genetic Testing

Children's Hospital of Philadelphia359 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

359

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

Percentage of Correct Items on Knowledge Questionnaire - Before Results

The primary outcome is the percentage of correct items on a genetic knowledge survey that was developed for this study, measured at baseline and before receipt of genetic test results. Participants evaluated included the primary caregivers, secondary caregivers and probands aged 12+. Total scores were generated by summarizing total number of correct responses and generating a percentage. The Genetic Knowledge measure included 12 true/false questions. Higher scores indicate higher genetic knowledge.

Time frame: Up to 4 weeks after testing

Secondary Outcomes

Percentage of Correct Items on Knowledge Questionnaire - After Results

A secondary analysis includes data from all caregivers' (primary and secondary) and probands' (over 12 years of age) of percentage of correct items on a genetic knowledge survey that was developed for this study, repeated at a second timepoint (T2) after receipt of genetic test results. The knowledge score is a 12-point true/false questionnaire. Total scores were generated by summarizing total number of correct responses and generating a percentage. The Genetic Knowledge measure included 12 true/false questions. Higher scores indicate higher genetic knowledge.

Time frame: Up to 6 months post-genetic test result

Acceptability of Use of an Informational Video on Paired Tumor/Normal Testing for Participants With a New Cancer or Other Diagnosis

Acceptability in all participants (primary caregivers, secondary caregivers and probands aged 12+) will be assessed using a questionnaire including the following measures: * Satisfaction with Decision Scale (SDS): 6-question decision satisfaction measure, scored on Likert scale from 1= strongly disagree to 5= strongly agree. Scores range from 0-30, higher scores indicate greater satisfaction. * Impact of Events Scale for cancer-specific distress (IES): 15-item questionnaire, scored on a Likert scale from 1 (Not at all)- 5 (Often). Total scores range from 0-75, higher scores indicate greater distress. Scores for intrusion subscale range from 0 to 35. The scores for the avoidance subscale range from 0 to 40. * Multidimensional Impact of Cancer Risk Assessment (MICRA) Distress Subscale is a 6-item questionnaire, scored on a Likert scale ranging from 0 (Never) to 5 (Often). Scores range from 0-30, higher scores indicate greater distress. Only sub/scales completed entirely were analyzed.

Data from ClinicalTrials.gov

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