Completed

NCT Number: NCT00489632

Children's Resiliency, Adjustment, and Coping

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Medical Center-Twin Cities, Minneapolis, Minnesota, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Behavioral

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

Other names: Survey

Primary outcomes

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

Time frame: 4 Years

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Children's Resiliency, Adjustment, and Coping: Cancer-Related, Family Context, and Within-Child Factors

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Jun 21, 2007
Registry last updated: Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed