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

NCT05849155 | Recruiting

• 1 other identifier: GCHAT
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Behavior Observations

  Multiple regression models will be conducted to assess whether demographic and clinical factors significantly relate to quality and style of observed communication variables, as assessed using the Iowa Family Interaction Rating Scales. Multiple regression models will also be conducted to investigate whether general family communication, parent adjustment, parent genetic knowledge, parent sense of efficacy, and perception of children as less vulnerable (as assessed by parent and CAYA reported measures) significantly relate to each of the five observed communication variables (observed distress, warmth/support, responsiveness, dismissiveness, and child-centeredness), as assessed using the Iowa Family Interaction Rating Scales.

  Day 0

• Qualitative Interviews

  Interview transcripts will be coded to identify barriers and facilitators of parent-CAYA communication regarding CAYA genomic risk for cancer. Interviews will undergo content and thematic analysis until saturation and consensus is reached. Themes will be compared between strata defined by degree of communication about cancer predisposition.

  Up to 4 years

• Multidimensional Impact of Cancer Risk Assessment (MICRA), modified

  A linear regression will be conducted to assess differences between observed communication qualities (behavior observations: distress, warmth/support, responsiveness, dismissiveness, and child-centeredness) and CAYA-reported impact of genetic testing disclosure.

  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

  A linear regression will be conducted to assess differences between observed communication qualities (behavior observations: distress, warmth/support, responsiveness, dismissiveness, and child-centeredness) and CAYA anxiety.

  Day 0

• PROMIS: Pediatric Short Form v2.0 - Depressive Symptoms 8a (age <17 years) and Short Form v1.0 - Depression 8a (age 18+ years)

  A linear regression will be conducted to assess differences between observed communication qualities (behavior observations: distress, warmth/support, responsiveness, dismissiveness, and child-centeredness) and CAYA depression/depressive symptoms.

  Day 0

• Cancer Risk and Prevention Knowledge Questionnaire (CPKQ)

  A linear regression will be conducted to assess differences between observed communication qualities (behavior observations: distress, warmth/support, responsiveness, dismissiveness, and child-centeredness) and CAYA-reported cancer risk and prevention knowledge.

  Day 0

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katianne Sharp, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katianne Sharp, PhD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 8, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)