NCT00477256

Brief Summary

Primary Objectives:

  1. 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. 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. 3.To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of child adjustment to pediatric cancer.
  4. 4.To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of school reintegration (i.e., school attendance).
  5. 5.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.
  6. 6.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.
  7. 7.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.
  8. 8.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

3.4 years

First QC Date

May 22, 2007

Last Update Submit

July 27, 2012

Conditions

Keywords

Pediatric CancerChild AdjustmentSchool ReintegrationCaregiverQuestionnaireQuality of LifeSurvey

Outcome Measures

Primary Outcomes (2)

  • Severity of Illness [using The Severity of Illness Scale (SOIS)]

    Completion of scale by medical staff, approximately 2-5 minutes

  • Quality of Life [using The Pediatric Quality of Life (PedsQL)]

    Questionnaire, approximately 45 minutes to one hour for parent or non-parent caregivers to complete their measures

Study Arms (3)

Child

Children between 6 and 17 years diagnosed with, and treated for, any type of cancer.

Behavioral: Questionnaires

Parent

Parent(s) or caregiver(s) of children with cancer.

Behavioral: Questionnaires

Medical Staff

Medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making.

Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

5 Paper-and-Pencil Questionnaires: All participants will engage in a one-time completion of all measures.

Also known as: Survey
ChildMedical StaffParent

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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)
  • Children and/or parents who speak a language other than English or Spanish
  • Participant (e.g., parent or child) unwillingness to participate in any capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Martha Askins, PhD, BA, MA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 23, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations