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Recruiting NCT05849155

Barriers and Facilitators of Parent-Child Communication in Children With Cancer Predisposition

Observational Genetic Predisposition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Genetic Predisposition. Basic parameters: 10 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Testing children, adolescents, and young adults (CAYA) for a genetic risk for cancer can help with early prevention and detection of cancers through regular follow-ups and medical care. After receiving genetic test results, CAYA may not accurately understand what their results mean, and parents are often unsure about talking with their CAYA about their genetic risk for cancer. By understanding how parents communicate with their CAYA, the investigators can improve future genetic education to reduce cancer risk. Primary Objectives: * Identify qualities of parent-CAYA (child, adolescent, and young adults) communication about CAYAs' genomic cancer risk, and their association with CAYAs' psychosocial and prevention outcomes. * Examine the association between sociodemographic, cancer-related, and psychosocial factors and parent-CAYA communication regarding CAYAs' genomic risk for cancer. * Identify barriers and facilitators of parent-CAYA communication regarding CAYAs' genomic risk for cancer.

Detailed description

This sequential explanatory mixed-methods, multi-informant study will include CAYAs (ages 10-24 years) with a P/LP germline variant in a known cancer predisposition gene, with this age range selected to inform CAYA informational needs around transition to adult care. CAYAs and parents will complete questionnaires and direct behavioral observations of parent-CAYA communication to (1) observationally characterize the content, qualities, and associates of parent-CAYA cancer predisposition communication and (2) examine the association between qualities of parent-CAYA communication about CAYAs' cancer risk and CAYAs' psychosocial and prevention outcomes. A subset of CAYAs and parents (n = 40 each) will subsequently complete optional qualitative interviews. CAYAs and parents will be purposively selected for these interviews based on their observed communication to identify barriers and facilitators of parent-CAYA communication regarding genetic risk for cancer. Rigor and reproducibility are ensured through a multi-method, multi-informant design; a manualized approach to recruitment and data collection; standardized measures with sound psychometric properties when available (quant); rigorous statistical tests of proposed hypotheses (quant); data saturation and purposeful sampling for transferability (qual); and triangulation (qual)

Primary outcome measures

  • Behavior Observations [Time frame: Day 0]
  • Qualitative Interviews [Time frame: Up to 4 years]
  • Multidimensional Impact of Cancer Risk Assessment (MICRA), modified [Time frame: Day 0]
  • Patient-Reported Outcomes Measurement Information System (PROMIS): Pediatric Short Form v2.0 (age <17 years) and Short Form v1.0 (age 18+ years) - Anxiety 8a [Time frame: Day 0]
  • PROMIS: Pediatric Short Form v2.0 - Depressive Symptoms 8a (age <17 years) and Short Form v1.0 - Depression 8a (age 18+ years) [Time frame: Day 0]
  • Cancer Risk and Prevention Knowledge Questionnaire (CPKQ) [Time frame: Day 0]

Eligibility criteria

Inclusion criteria

  • Patient aged 10 to 24 years (inclusive)
  • Patient underwent germline genetic testing with a Pathogenic/Likely Pathogenic (P/LP) variant in a known cancer predisposition gene that increases risk for developing cancer
  • P/LP result disclosed to the patient
  • Patient has a primary caregiver willing to participate
  • Patient and participating caregiver able to speak and read English

Exclusion criteria

  • Patient is only a carrier of a recessive variant that does not alone increase risk for cancer
  • Inability or unwillingness of patient or participating caregiver or to give informed consent/assent
  • Participating caregiver is under the age of 18 years
  • Patient or participating caregiver has evidence of significant cognitive deficits (per medical record) that would interfere with the ability to comprehend study questions
  • Patient's medical status or condition precludes completion of study (as determined by medical team, patient, or parent)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • St. Jude Children's Research Hospital — Memphis

Identifiers

NCT: NCT05849155 · GCHAT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗