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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Posttraumatic Stress Disorder; Posttraumatic Growth

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.

• Study Type: Observational
• Enrollment (Actual): 663

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Use the Hemingway measure of social connectedness, and the Behavioral Assessment Scale for Children, 2nd Edition (BASC-2) by child, parent and teacher report.	5 years post study entry
Compare data obtained electronically versus data obtained on paper for reliability and outcomes obtained.		5 years post study entry

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sean Phipps, Ph.D, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2009
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): July 7, 2026

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimated): January 7, 2010

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cancer as trauma in children; PTG/PTSS/ PTSD in children with cancer vs healthy children
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: PTSD2; R01CA136782 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No