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School Reintegration Outcomes in Pediatric Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00477256
First received: May 22, 2007
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

Primary Objectives:

  1. To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors or correlates of child adjustment to pediatric cancer.
  2. To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors of school reintegration (i.e., school attendance) in children with pediatric cancer.
  3. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of child adjustment to pediatric cancer.
  4. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of school reintegration (i.e., school attendance).

Secondary Objectives:

  1. To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of child adjustment to pediatric cancer.
  2. To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of school reintegration (i.e., school attendance) in children with pediatric cancer.
  3. To develop a statistical model by which relative contributions of each predictor variable (i.e., severity of illness, quality of life, parental stress, parental perception of child vulnerability), as well as their interrelatedness, can be understood in relation to child adjustment. Exploration of each variable's contribution will affect the schematic organization of the model.
  4. To examine demographic variables as covariates in the primary analyses. The variables include: child's age, gender, grade, ethnicity, diagnosis, time since diagnosis, type and duration of treatment, and time since school reintegration.

Condition Intervention
Pediatric Cancers
Behavioral: Questionnaires

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Psychosocial Predictors of Child Adjustment and School Reintegration Outcome in a Pediatric Cancer Population

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Severity of Illness [using The Severity of Illness Scale (SOIS)] [ Time Frame: Completion of scale by medical staff, approximately 2-5 minutes ] [ Designated as safety issue: No ]
  • Quality of Life [using The Pediatric Quality of Life (PedsQL)] [ Time Frame: Questionnaire, approximately 45 minutes to one hour for parent or non-parent caregivers to complete their measures ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: May 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Child
Children between 6 and 17 years diagnosed with, and treated for, any type of cancer.
Behavioral: Questionnaires
5 Paper-and-Pencil Questionnaires: All participants will engage in a one-time completion of all measures.
Other Name: Survey
Parent
Parent(s) or caregiver(s) of children with cancer.
Behavioral: Questionnaires
5 Paper-and-Pencil Questionnaires: All participants will engage in a one-time completion of all measures.
Other Name: Survey
Medical Staff
Medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making.
Behavioral: Questionnaires
5 Paper-and-Pencil Questionnaires: All participants will engage in a one-time completion of all measures.
Other Name: Survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children between 6 and 17 years diagnosed with, and treated for, any type of cancer, their parent(s) or caregiver(s), and medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making.

Criteria

Inclusion Criteria:

  1. Children between 6 and 17 years diagnosed with, and treated for, any type of cancer
  2. Children enrolled in grades K through 12
  3. Children who have actively participated in community or private school during the 2006-2007 academic year
  4. Children who have experienced a period of absence from community or private school of at least two consecutive months as a result of medical treatment prior to school reintegration
  5. Children who have fully reintegrated as a full-time student within the past 1-3 years
  6. Parents and children who are either English- or Spanish-speaking and are able to read in either or both languages
  7. Medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making

Exclusion Criteria:

  1. Children and/or parents diagnosed and/or identified as having mental retardation (IQ < 70) with concomitant adaptive behavior deficits or classified as having any type of Pervasive Developmental Disorder (PDD)
  2. Children and/or parents who speak a language other than English or Spanish
  3. Participant (e.g., parent or child) unwillingness to participate in any capacity
  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: NCT00477256

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Martha Askins, PhD, BA, MA M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00477256     History of Changes
Other Study ID Numbers: 2007-0007
Study First Received: May 22, 2007
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Pediatric Cancer
Child Adjustment
School Reintegration
Caregiver
Questionnaire
Quality of Life
Survey

ClinicalTrials.gov processed this record on November 24, 2014