Barriers and Facilitators of Parent-Child Communication in Children With Cancer Predisposition (NCT05849155) | Clinical Trial Compass
RecruitingNot Applicable
Barriers and Facilitators of Parent-Child Communication in Children With Cancer Predisposition
United States125 participantsStarted 2023-12-12
Plain-language 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.
Who can participate
Age range
10 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Behavior Observations
Timeframe: Day 0
2
Qualitative Interviews
Timeframe: Up to 4 years
3
Multidimensional Impact of Cancer Risk Assessment (MICRA), modified
Timeframe: Day 0
4
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
5
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
6
Cancer Risk and Prevention Knowledge Questionnaire (CPKQ)