NCT00489632

Brief Summary

Overall Objective: The overall objective of this cross-sectional psychosocial study is to examine illness-related factors, family context factors, and child resiliency as predictors or correlates of child adjustment to leukemia treatment. Primary Objective 1: 1(a): To examine illness-related factors (i.e., child's health and physical functioning and severity of the child's illness) as predictors of child psychological adjustment to leukemia. 1(b): To examine relapse status as a grouping variable affecting child psychological adjustment to leukemia. 1(c): To examine stage of treatment as a grouping variable affecting child psychological adjustment to leukemia. Primary Objective 2:

  • To examine family context factors (i.e., family psychosocial risk and parental emotional distress) as correlates of child psychosocial adjustment to leukemia treatment. Primary Objective 3:
  • To examine child resiliency as a predictor of child psychological adjustment to leukemia treatment. Secondary Objectives:
  • One secondary objective of the study is to examine parental distress as a moderator affecting parental report of child adjustment to leukemia as compared to the child's self-report of adjustment.
  • Another secondary objective of the study is to develop a model by which the relative contribution of each predictor variable (as determined by analyses of primary objectives) as well as their interrelatedness can be understood in relation to child psychosocial adjustment.
  • A third secondary objective of the study is to examine demographic variables as covariates in the main analyses. These variables include: age, grade, site, gender, ethnicity, type of leukemia, staging, time spent in treatment, age at diagnosis, and whether the child is undergoing standard or experimental treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

April 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

4.8 years

First QC Date

June 20, 2007

Last Update Submit

February 17, 2012

Conditions

Leukemia

Keywords

LeukemiaPediatricsCancerCopingCaregiverQuestionnaireChildrenResiliencyAdjustmentIllness-related factors

Outcome Measures

Primary Outcomes (1)

  • Illness-related factors as predictors of child psychological adjustment to leukemia

    4 Years

Study Arms (1)

Questionnaire

Children with leukemia and their families/caregivers.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaires administered to pediatric patients and their parent(s) or caregiver(s).

Also known as: Survey
Questionnaire

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with a diagnosis of leukemia and their parent(s) or caregiver(s).

You may qualify if:

  • Child who is 6 to 18 years of age or the parent or clinician of a child 6 to 18 years of age.
  • The child has a diagnosis of any type of leukemia
  • Child and at least one parent or non-parent caregiver must speak and read either English or Spanish well enough to complete questionnaires with some reading assistance from the researcher.
  • Child is currently receiving chemotherapy treatment

You may not qualify if:

  • If the child is currently in a medical crisis as determined by his/her primary physician (e.g., ICU admission, hospice care), he/she will not be considered for participation.
  • If the child and/or parent or non-parent caregiver is unable to comprehend the survey questions, they will be excluded from participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Minnesota Medical Center-Twin Cities

Minneapolis, Minnesota, 55455, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaNeoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic Diseases

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

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

April 1, 2006

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

US(2)