Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT05849155

Conditions

Genetic Predisposition

Eligibility Criteria

Sex: All

Age: 10 - 24

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Genetic Predisposition

Study ID

NCT05849155

Start date

Dec 12, 2023

Status verified date

Apr, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 24

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Katianne Sharp, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-04-23.