NCT04848142

Psychosocial Impact of Disclosing Cancer Predisposition Genetic Testing Results During Childhood

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 199 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A mixed methods approach, including questionnaires and qualitative interviews with children and their parents. Participants ("Primary Strata:" parents (i.e., guardians/caregivers) and children age ≥ 8 years, n=132; "Parent Only Strata:" parents of children age \< 8 years, n=66) will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. Optional qualitative interviews may be completed individually for participants (age ≥ 12 years, n=30) with P/LP variants (and who are aware of their result status) and their parents (n=30) to obtain more open-ended information about the impact of genetic testing result disclosure, family communication about testing results, and their perception of result implications.

Conditions

• Pediatric Cancer
• Predisposition, Genetic

Timeline

• Start date: 2021-05-07
• Primary completion: 2023-10-13
• Completion: 2023-10-13
• First posted: 2021-04-19
• Last updated: 2023-10-18

Locations

1 site across 1 country: United States