Leukemia Clinical Trial
Official title:
Children's Resiliency, Adjustment, and Coping: Cancer-Related, Family Context, and Within-Child Factors
Verified date | February 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Years to 18 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
United States | University of Minnesota Medical Center-Twin Cities | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Illness-related factors as predictors of child psychological adjustment to leukemia | 4 Years | Yes |
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