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


N/A
3 Years
25 Years
Open (Enrolling)
Both
Posttraumatic Growth, Posttraumatic Stress Disorder

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

5 years post study entry

Safety Issue:

No

Principal Investigator

Sean Phipps, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

PTSD2

NCT ID:

NCT01044160

Start Date:

June 2009

Completion Date:

December 2018

Related Keywords:

  • Posttraumatic Growth
  • Posttraumatic Stress Disorder
  • cancer as trauma in children
  • PTG/PTSS/ PTSD in children with cancer vs healthy children
  • Stress Disorders, Post-Traumatic
  • Stress Disorders, Traumatic

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794