Clinical trial NCT05849155: Barriers and Facilitators of Parent-Child Communication in Children With Cancer Predisposition
Official title: Barriers and Facilitators of Parent-Child Communication in Children With Cancer Predisposition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genetic Predisposition
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 125
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, adolescents, and young adults (CAYAs) aged 10-24 years with a pathogenic/likely pathogenic variant in a known cancer predisposition gene and their parents

Brief summary: 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)

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)

Primary outcomes:
measure: Behavior Observations
timeFrame: Day 0
measure: Qualitative Interviews
timeFrame: Up to 4 years
measure: Multidimensional Impact of Cancer Risk Assessment (MICRA), modified
timeFrame: Day 0
measure: 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
timeFrame: Day 0
measure: PROMIS: Pediatric Short Form v2.0 - Depressive Symptoms 8a (age <17 years) and Short Form v1.0 - Depression 8a (age 18+ years)
timeFrame: Day 0
measure: Cancer Risk and Prevention Knowledge Questionnaire (CPKQ)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Katianne Sharp, PhD
role: PRINCIPAL_INVESTIGATOR
References: