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Children's Resiliency, Adjustment, and Coping: Cancer-Related, Family Context, and Within-Child Factors
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.
Parental Consent/Child Assent for Child Participants: If you choose to take part in this study, you will be asked to complete a total of 2 or 3 questionnaires (depending on your age). Each questionnaire will be completed only once. If you are between 6-7 years old, you will be given 2 questionnaires asking you about your physical health and illness, and your personal strengths. These questionnaires will take you about 30-45 minutes to finish. If you are between 8-18 years old, you will be given 3 questionnaires that will ask you about your physical health and illness, your personal strengths, and your emotional adjustment to the disease. These 3 questionnaires will take you about 30-45 minutes in total to finish. A research assistant will help you with the questionnaires, if you need help. If you are given the questionnaires while you are at the hospital and you cannot complete them before you leave, you will be given a stamped envelope to mail the forms back to the study staff. After your questionnaires are finished, a member of the research team might look at your medical chart if they need more information about your treatment or the status of the disease. Parent Participants: If you choose to take part in this study, you will be asked to complete a total of 5 questionnaires. These questionnaires ask information about your child's emotional adjustment to the disease, your child's physical health and illness, your child's personal strengths, your emotional distress, and the overall functioning of your family. Each questionnaire will be completed only once. It will take about 45-60 minutes to complete all 5 questionnaires. Medical Staff Participants: If you choose to take part in this study, you will be asked to complete a questionnaire that asks for information about the patient's illness. It will take about 3-5 minutes to complete this one-time survey. All Groups: This is an investigational study. About 220 people (100 children, 100 parents, and 20 medical staff) will take part in this multicenter study. About 130 will be enrolled at M. D. Anderson (60 children, 60 parents, and 10 medical staff members).
Age
6 - 18 years
Sex
ALL
Healthy Volunteers
Yes
University of Minnesota Medical Center-Twin Cities
Minneapolis, Minnesota, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
Start Date
April 1, 2006
Primary Completion Date
January 1, 2011
Completion Date
January 1, 2011
Last Updated
February 20, 2012
66
ACTUAL participants
Questionnaire
BEHAVIORAL
Lead Sponsor
M.D. Anderson Cancer Center
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06311227