Stress, Adjustment And Growth In Children With Cancer And Their Parents (NCT01044160) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Stress, Adjustment And Growth In Children With Cancer And Their Parents
United States663 participantsStarted 2009-07-07
Plain-language summary
This proposal examines trauma and growth responses in the childhood cancer experience. It addresses a number of gaps and unanswered questions in the literature, while integrating several distinct but related lines of research. The rationale for this proposal is outlined briefly as follows:
1. Traumatic stress models focused on pathology dominate pediatric psychosocial oncology research despite empiric evidence of low levels of post-traumatic stress in this population.
2. The assumption of 'cancer as a traumatic event' has biased research designs (including lack of control comparisons) to focus on deficits and pathological outcomes.
3. This deficit-oriented approach has stimulated the development of interventions to treat or prevent PTSD, which may be unnecessary or even harmful.
4. Theoretical and empiric evidence suggests that a more common response to traumatic stress is growth and positive change, but posttraumatic growth phenomenon have been understudied in pediatric populations.
5. Cognitive and personality factors are important determinants of PTSD and positive growth outcomes, and some constructs from positive psychology theory may be particularly relevant in children with cancer.
6. Empirically, parents of children with cancer appear to be at higher risk of PTSD/PTSS, although results are not unequivocal, and the same research biases have applied to parental outcomes. This proposal includes assessment of parental PTSS and PTG, both as an outcome and a predictor of child outcomes.
Who can participate
Age range
3 Years – 25 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:
Primary Group
* Research participant is 8-17 years inclusive
* Research participant has a primary diagnosis of malignancy
* Research participant is at least one month from diagnosis with no upper limit in terms of time elapsed since diagnosis;
* Research participant is able to speak and read English;
* Research participant does not have any significant cognitive or sensory deficits that would preclude participation;
* Parent/LAR and research participant is willing to participate and provide consent/assent
Young Child Group
* Research participant is 3 - 6 years of age, inclusive
* Primary diagnosis of malignancy
* At least one month from diagnosis
* One parent/LAR willing to participate and provide consent
* No history of sensory or developmental disorder that would invalidate study assessment procedures.
Young Adult Group
* Research participant is 18-25 years of age inclusive
* Primary diagnosis of malignancy
* At least one month from diagnosis with no upper limit in terms of time elapsed from diagnosis
* Able to read and speak English
* No cognitive or sensory deficits that would preclude participation
* Willing to participate and provide consent
Control Groups
* Research participant in 3 age groups (3 - 6 years; 8-17 years; 18-25 years) to match patient groups
* No history of chronic or life-threatening illness
* No cognitive or sensory impairment that would preclude completion of study measures
* Able to speak and read English
* Parent/LAR and r…
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.
1Since this study is comparing children with cancer or cancer survivors to children without serious illness, would my child be contributing information that could help researchers understand the psychological journey of kids going through cancer treatment specifically?
2This study is looking at both posttraumatic stress and posttraumatic growth — does my child's care team already screen for these outcomes, and how would participating in this study differ from the mental health support my child is currently receiving?
3The study is examining predictors like family environment and personality variables — what kinds of questions or assessments would my child and our family actually be asked to complete, and how demanding would that be given everything else we're managing right now?
4Since this study is active but no longer enrolling new participants, is there a similar observational or psychological support study currently open that my child might still be eligible to join?
5Given that this research is focused on measuring psychological outcomes rather than testing a treatment, what steps is our care team already taking to monitor and support my child for posttraumatic stress, and would the findings from a study like this change how they approach that support?
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
Examine outcomes of posttraumatic growth and benefit finding (PTG) in children with cancer/cancer survivors in comparison to a population of children without history of serious illness.
Timeframe: 5 years post study entry
2
Examine outcomes of posttraumatic stress (PTSS/PTSD) in children with cancer/cancer survivors in comparison to children without a history of serious illness.
Timeframe: 5 years post study entry
3
Examine predictors of child posttraumatic stress and posttraumatic growth from medical variables, life events history, family environment, and child personality variables.
Timeframe: 5 years post study entry
4
Examine difference in trajectories of pathological outcomes and positive outcomes between children with cancer/cancer survivors and children without a history of serious illness.