Genetic PredispositionNCT05849155
Barriers and Facilitators of Parent-Child Communication in Children With Cancer Predisposition
An observational study of Genetic Predisposition, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 24 years
- Conditions the study is for
- Genetic Predisposition
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
888-226-4343, referralinfo@stjude.org
About this study
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.
Read the 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)
- Conditions
- Genetic Predisposition
- Medical subject headings
- Genetic Predisposition to Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start12 Dec 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic PredispositionStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katianne Sharp, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849155
- Sponsor's protocol ID
- GCHAT
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Facilitators of Parent-Child Communication in Children With Cancer Predisposition
- ClinicalTrials.gov ID
- NCT05849155
- Acronym / sponsor ID
- GCHAT
- Conditions
- Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Behavior Observations
Time frame: Day 0
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.
Qualitative Interviews
Time frame: Up to 4 years
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.
Multidimensional Impact of Cancer Risk Assessment (MICRA), modified
Time frame: Day 0
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.
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
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.
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
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.
Cancer Risk and Prevention Knowledge Questionnaire (CPKQ)
Time frame: Day 0
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katianne Sharp, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katianne Sharp, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Observations (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.