Children's Resiliency, Adjustment, and Coping
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Leukemia |
Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Children's Resiliency, Adjustment, and Coping: Cancer-Related, Family Context, and Within-Child Factors |
- Illness-related factors as predictors of child psychological adjustment to leukemia [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
| Enrollment: | 66 |
| Study Start Date: | April 2006 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Questionnaire
Children with leukemia and their families/caregivers.
|
Behavioral: Questionnaire
Questionnaires administered to pediatric patients and their parent(s) or caregiver(s).
Other Name: Survey
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Children with a diagnosis of leukemia and their parent(s) or caregiver(s).
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.
Contacts and Locations| United States, Minnesota | |
| University of Minnesota Medical Center-Twin Cities | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Martha Askins, PhD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00489632 History of Changes |
| Other Study ID Numbers: | 2005-0628 |
| Study First Received: | June 20, 2007 |
| Last Updated: | February 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Leukemia Pediatrics Cancer Coping Caregiver |
Questionnaire Children Resiliency Adjustment Illness-related factors |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013