Leukemia Clinical Trial
Official title:
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).
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Observational Model: Case-Only, Time Perspective: Prospective
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