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

NCT01044160 | Active Not Recruiting

• 2 other identifiers: PTSD2R01CA136782
• Study Type: observational
• Target: 663
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.This deficit-oriented approach has stimulated the development of interventions to treat or prevent PTSD, which may be unnecessary or even harmful.
4. 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. 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. 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.

Conditions

Posttraumatic Growth; Posttraumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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 entry

Study Arms (2)

Oncology Group

The study will recruit from outpatient clinics with procedures designed to obtain a representative sample of research participants, in terms of diagnosis and time since diagnosis.

Control Group

The study will first identify a large cohort of children who are willing to participate, and then call them back individually as they are found to match participants in the cancer group.

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Recruitment from the oncology group will be from outpatient clinics with procedures designed to obtain a representative sample of research participants, in terms of diagnosis and time since diagnosis. Control group participants will be accessed through schools in the greater Memphis area.

You may qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Sean Phipps, Ph.D

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: July 7, 2009
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): July 7, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)