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NCT01044160 · ClinicalTrials.gov record · last posted 2026-08-24

Stress, Adjustment And Growth In Children With Cancer And Their Parents

StatusActive, Not Recruiting
PhaseNot specified
Started2009-07-07
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from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-25
critical
Primary completion pushed: 2026-07-07 → 2029-04-30
2026-08-25
minor
Completion pushed: 2026-07-07 → 2029-04-30
Trial Details
NCT Number NCT01044160
Lead Sponsor St. Jude Children's Research Hospital
Collaborators: National Cancer Institute (NCI)
Conditions Posttraumatic Growth, Posttraumatic Stress Disorder
Enrollment 663 participants
Start Date 2009-07-07
Primary Completion 2029-04-30 (estimated)
Study Completion 2029-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-24