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MinorPrimary and study completion dates: Dec 2020 to Dec 31, 2020Start date: Jun 2009 to Jul 7, 2009v15Show 1 more changeShow less
Start date: Jun 2009 to Jul 7, 2009
MinorTrial status: Recruiting to Active, Not RecruitingSite details revisedv14Show 1 more changeShow less
Site details revised
MinorSite contact updatedv13
NotablePrimary and study completion dates: Dec 2018 to Dec 2020v12
Minor4 versionsRe-verified since Apr 8, 2013, no change to tracked fieldsv8-v11
NotablePrimary and study completion dates: Feb 2015 to Dec 2018Secondary endpoints: details revised at 6 of 6 entries · Study description expanded, about 13 wordsv7Show 2 more changesShow less
Secondary endpoints: details revised at 6 of 6 entries
NotablePrimary and study completion dates: Feb 2013 to Feb 2015Primary endpoints: 3 to 4 · Secondary endpoints: 4 to 6 · Study description expanded, about 86 wordsv5Show 3 more changesShow less
NotablePrimary and study completion dates: Feb 2012 to Feb 2013v4
MinorRe-verified, no change to tracked fieldsv3
MinorEligibility criteria expanded, about 13 wordsSecondary endpoints: 3 to 4 · Study description expanded, about 21 words · Study title revisedv2Show 3 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.