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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01044160
Enrollment
663
Registered
2010-01-07
Start date
2009-07-07
Completion date
2029-04-30
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Growth, Posttraumatic Stress Disorder

Keywords

cancer as trauma in children, PTG/PTSS/ PTSD in children with cancer vs healthy children

Brief 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.

Detailed description

This study examines the following outcomes: 1. To 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. 2. To examine outcomes of posttraumatic stress (PTSS/PTSD) in children with cancer/cancer survivors in comparison to children without a history of serious illness. 3. To examine predictors of child posttraumatic stress and posttraumatic growth from medical variables, life events history, family environment, and child personality variables. 4. To apply an accelerated longitudinal design to examine trajectories of both pathological outcomes such as posttraumatic stress (PTSS) and positive outcomes such as challenge-related growth (CRG) in children with cancer/cancer survivors in comparison to a population of children without a history of serious illness. Additional observations will be obtained at 1-, 3-, and 5-years post study entry. 5. To examine outcomes of PTG and PTSS/PTSD in parents of children with cancer/cancer survivors in comparison to parents of healthy children. Parental PTSS/PTSD and PTG will be examined both as outcomes and as predictors of child outcomes. 6. To examine predictors of parent PTSS/PTSD and PTG from demographic and medical variables, life events history, and parent personality variables. 7. To determine the sensitivity/specificity of measures of PTSS in screening for PTSD based on diagnostic interview. 8. To examine the validity and reliability of a new measure of child personality, the Child and Adolescent Five Factor Inventory (CAFFI). 9. To examine emerging social developmental outcomes in this longitudinal cohort. 10. To develop an electronic version of the study measures and to compare data obtained electronically (on desktop or laptop computer), with data obtained on paper for comparability in reliability and outcomes obtained.

Interventions

None listed

Sponsors

St. Jude Children's Research Hospital
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 25 Years
Healthy volunteers
Yes

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 research participant are willing to participate and provide informed consent/assent Exclusions Criteria:NA

Design outcomes

Primary

MeasureTime frame
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.5 years post study entry
Examine outcomes of posttraumatic stress (PTSS/PTSD) in children with cancer/cancer survivors in comparison to children without a history of serious illness.5 years post study entry
Examine predictors of child posttraumatic stress and posttraumatic growth from medical variables, life events history, family environment, and child personality variables.5 years post study entry
Examine difference in trajectories of pathological outcomes and positive outcomes between children with cancer/cancer survivors and children without a history of serious illness.5 years post study entry

Secondary

MeasureTime frameDescription
Examine outcomes of PTG and PTSS/PTSD in parents of children with cancer/cancer survivors in comparison to parents of healthy children. Parental PTSS/PTSD and PTG will be examined both as outcomes and as predictors of child outcomes.5 years post study entry
Examine predictors of parent PTSS/PTSD and PTG from demographic and medical variables, life events history, and parent personality variables.5 years post study entry
Determine the sensitivity/specificity of measures of PTSS in screening for PTSD based on diagnostic interview.5 years post study entry
Examine the validity and reliability of a new measure of child personality, the Child and Adolescent Five Factor Inventory (CAFFI).5 years post study entry
Describe emerging social developmental outcomes in the longitudinal cohort.5 years post study entryUse the Hemingway measure of social connectedness, and the Behavioral Assessment Scale for Children, 2nd Edition (BASC-2) by child, parent and teacher report.
Compare data obtained electronically versus data obtained on paper for reliability and outcomes obtained.5 years post study entry

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSean Phipps, Ph.D

St. Jude Children's Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026