MDACC Study Summary 2005-0628 (Archived)

Study Summary
No. 2005-0628:.......Leukemia; Pediatrics......Martha Askins......Pediatrics

Study Summary Title



Study Summary Number:	2005-0628

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

Physician

New Patient Referral



Name:	Martha Askins	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-4467 Contact us about clinical trials

General Information



Disease Group:	Leukemia Pediatrics	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Participants are not required to come to MDACC for participation in the study. If they are going to be here for medical treatment, they may complete the measures at the same time. If they are not going to be here, they can be completed via mail.

Treatment Agents:	None	Home Care:	No treatment will be provided in this study.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Patients' length of stay will only depend on their medical treatment, and will have no bearing on their participation in the study, nor will the study affect their length or frequency of hospitalization.


Description/ Intervention:	The goal of this behavioral research study is to find out if children's emotional adjustment to the disease is affected by the physical impact of leukemia, the emotional impact of leukemia on the family, and the personal strengths of the child.

Study Objectives / Outcomes

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.

Objective 1

Objective 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.

Objective 1(b): To examine relapse status as a grouping variable affecting child psychological adjustment to leukemia.

Objective 1(c): To examine stage of treatment as a grouping variable affecting child psychological adjustment to leukemia.

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.

Objective 3: To examine child resiliency as a predictor of child psychological adjustment to leukemia treatment.

Secondary Objectives

Secondary Objective 1: 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.

Secondary Objective 2: 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.

Secondary Objective 3: 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.

Study Status Information



Study Activation / Registration Date:	04/28/2006

IRB Review and Approval Date:	04/28/2006

Study Type:	Behavioral

Recruitment Status:	Terminated

Projected Accrual:	220 total participants (children, parents or non-parent caregivers, and medical staff members) at both MDACC (N=130) and the University of Minnesota (N=90)

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Child who is 6 to 18 years of age or the parent or clinician of a child 6 to 18 years of age.

2) The child has a diagnosis of any type of leukemia

3) 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.

4) Child is currently receiving chemotherapy treatment

Exclusion Criteria:

1) 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.

2) If the child and/or parent or non-parent caregiver is unable to comprehend the survey questions, they will be excluded from participation.

Links

Registration Number: NCT00489632
Study Information on Clinical Trials Registry (clinicaltrials.gov)