Status:
COMPLETED
Psychosocial Impact of Disclosing Cancer Predisposition Genetic Testing Results During Childhood
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Pediatric Cancer
Predisposition, Genetic
Eligibility:
All Genders
8+ years
Brief 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 particip...
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...
Eligibility Criteria
Inclusion
- Primary Strata
- Patient underwent germline genetic testing as offered through the SJCRH Cancer Predisposition Program with results disclosed to patient and/or parents (i.e., of testing results are not a criterion for eligibility)
- Patient's age at the time of initial germline result disclosure was birth - 17 years of age (inclusive)
- Patient had diagnosis of malignancy (or benign tumor; e.g., craniopharyngioma) prior to germline testing
- A parent/legal guardian/caregiver is willing to participate in the research study and provide consent
- Participant family is fluent in English for completion of questionnaires (able to speak and read)
- Patient is currently 8 years of age or older
- Parent Only Strata
- Parent (i.e., guardian/caregiver) of a patient who underwent germline genetic testing as offered through the SJCRH Cancer Predisposition Program with results disclosed to patient and/or parents 1 - 3 years (inclusive) previously (Note- patient's knowledge of testing results are not a criterion for eligibility)
- Parent of a patient whose age at the time of initial germline result disclosure was birth - 17 years of age (inclusive)
- Parent of a patient with a diagnosis of malignancy (or benign tumor; e.g., craniopharyngioma) prior to germline testing
- Parent/caregiver is a legal guardian willing to participate in the research study and provide consent
- Participant family is fluent in English for completion of questionnaires (able to speak and read).
- Parent of a patient currently younger than 8 years of age.
Exclusion
- Inability or unwillingness of research participant or parent (i.e., guardian/caregiver) to give informed consent
- Parent is under the age of 18 years
- Parent has evidence of significant cognitive deficits (per medical report) that would interfere with the ability to comprehend questionnaires
- Research participant's medical status or condition precludes completion of the study (as determined by the medical team, patient, or parent)
Key Trial Info
Start Date :
May 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 13 2023
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT04848142
Start Date
May 7 2021
End Date
October 13 2023
Last Update
October 18 2023
Active Locations (1)
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1
St.Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105