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NCT04848142 · ClinicalTrials.gov registry record
Psychosocial Impact of Disclosing Cancer Predisposition Genetic Testing Results During Childhood
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 199
- Enrollment target
NCT04848142: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT04848142 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 199 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04848142 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 199 participants
- Enrollment target
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.
Primary Outcome
Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Fear of Cancer Recurrence - Short Form. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2021-05-07 |
| Est. Completion | 2023-10-13 |
What the finished NCT04848142 record still lists
NCT04848142 is an observational study that tracks outcomes without assigning an intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04848142 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04848142 about?
NCT04848142 is a clinical study titled "Psychosocial Impact of Disclosing Cancer Predisposition Genetic Testing Results During Childhood". 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 a...
What is the current status of trial NCT04848142?
This trial is currently completed. The enrollment target is 199 participants. The study started on 2021-05-07. Estimated completion is 2023-10-13.
Who is sponsoring clinical trial NCT04848142?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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