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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Jude Children's Research Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01044160
First received: January 5, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.

Condition
Posttraumatic Growth
Posttraumatic Stress Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Stress, Adjustment And Growth In Children With Cancer And Their Parents

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]
  • Examine outcomes of posttraumatic stress (PTSS/PTSD) in children with cancer/cancer survivors in comparison to children without a history of serious illness. [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]
  • Examine predictors of child posttraumatic stress and posttraumatic growth from medical variables, life events history, family environment, and child personality variables. [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]
  • Examine difference in trajectories of pathological outcomes and positive outcomes between children with cancer/cancer survivors and children without a history of serious illness. [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]
  • Examine predictors of parent PTSS/PTSD and PTG from demographic and medical variables, life events history, and parent personality variables. [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]
  • Determine the sensitivity/specificity of measures of PTSS in screening for PTSD based on diagnostic interview. [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]
  • Examine the validity and reliability of a new measure of child personality, the Five Factor Personality Inventory for Children (FFPIC). [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]
  • Describe emerging social developmental outcomes in the longitudinal cohort. [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]
    Use 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. [ Time Frame: 5 years post study entry ] [ Designated as safety issue: No ]

Estimated Enrollment: 716
Study Start Date: June 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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 Five Factor Personality Inventory for Children (FFPIC).
  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.
  Eligibility

Ages Eligible for Study:   3 Years to 25 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

Primary Group

  1. Research participant is 8-17 years inclusive
  2. Research participant has a primary diagnosis of malignancy
  3. Research participant is at least one month from diagnosis with no upper limit in terms of time elapsed since diagnosis;
  4. Research participant is able to speak and read English;
  5. Research participant does not have any significant cognitive or sensory deficits that would preclude participation;
  6. Parent/LAR and research participant is willing to participate and provide consent/assent

Young Child Group

  1. Research participant is 3 - 6 years of age, inclusive
  2. Primary diagnosis of malignancy
  3. At least one month from diagnosis
  4. One parent/LAR willing to participate and provide consent
  5. No history of sensory or developmental disorder that would invalidate study assessment procedures.

Young Adult Group

  1. Research participant is 18-25 years of age inclusive
  2. Primary diagnosis of malignancy
  3. At least one month from diagnosis with no upper limit in terms of time elapsed from diagnosis
  4. Able to read and speak English
  5. No cognitive or sensory deficits that would preclude participation
  6. Willing to participate and provide consent

Control Groups

  1. Research participant in 3 age groups (3 - 6 years; 8-17 years; 18-25 years) to match patient groups
  2. No history of chronic or life-threatening illness
  3. No cognitive or sensory impairment that would preclude completion of study measures
  4. Able to speak and read English
  5. Parent/LAR and research participant are willing to participate and provide informed consent/assent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044160

Contacts
Contact: Sean Phipps, Ph.D 1-866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Sean Phipps, Ph.D    866-278-5833    info@stjude.org   
Principal Investigator: Sean Phipps, Ph.D         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Sean Phipps, Ph.D St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01044160     History of Changes
Other Study ID Numbers: PTSD2, R01CA136782
Study First Received: January 5, 2010
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
cancer as trauma in children
PTG/PTSS/ PTSD in children with cancer vs healthy children

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014