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Psychosocial Impact of Disclosing Cancer Predisposition Genetic Testing Results During Childhood

NCT04848142 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 199

Last updated 2023-10-18

No results posted yet for this study

Summary

The participants are being asked to take part in this research study because the participant is a child who has been diagnosed with cancer and has completed genetic testing to find out if the participant has a variant in a gene that may predispose the participant to cancer, and/or the participants are the parents (i.e., guardian/caregiver) of this child. This research is being done to understand how finding out the results of genetic testing during childhood impacts the participant and family. The investigator will compare the emotions and behavior of parents and children based on the genetic testing results.

Primary Objective

* Examine the impact of genetic testing result disclosure for a pathogenic (P)/likely pathogenic (LP) germline variant in a known cancer predisposing gene versus negative results on parent adjustment (i.e., emotional functioning, cancer worry, symptom interpretation, and genetic testing related worry/distress).
* Examine the impact of genetic testing result disclosure for a P/LP germline variant versus negative results on parenting (i.e., responses to children's symptoms, overprotectiveness, parent-child communication, cohesion, and expressivity in the family).

Exploratory Objectives

* Examine the impact of genetic testing result disclosure (P/LP versus negative results) on child adjustment (i.e. emotional functioning, cancer worry, self-perception, and life meaning and purpose).
* Examine the impact of disclosing a variant of uncertain significance (VUS) on parent adjustment, parenting, and child adjustment.
* Examine the indirect association between genetic testing result disclosure (P/LP versus negative results) and child adjustment through parental adjustment and parenting behavior.
* Qualitatively identify children and parents' perspectives of how disclosure of a cancer predisposition has affected children's emotional, social, personal, and familial functioning.

Conditions

  • Pediatric Cancer
  • Predisposition, Genetic

Sponsors & Collaborators

Principal Investigators

  • Katianne Sharp, PhD · St. Jude Children's Research Hospital

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2023-10-13
Completion
2023-10-13

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04848142 on ClinicalTrials.gov