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临床试验/NCT00477256
NCT00477256已完成不适用

Psychosocial Predictors of Child Adjustment and School Reintegration Outcome in a Pediatric Cancer Population

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Severity of Illness [using The Severity of Illness Scale (SOIS)]

研究概览

简要总结

Primary Objectives:

  1. To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors or correlates of child adjustment to pediatric cancer.
  2. To examine illness-related factors (i.e., severity of illness, quality of life rating) as predictors of school reintegration (i.e., school attendance) in children with pediatric cancer.
  3. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of child adjustment to pediatric cancer.
  4. To examine a within-parent factor (i.e., parental stress) as a predictor or correlate of school reintegration (i.e., school attendance).

Secondary Objectives:

  1. To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of child adjustment to pediatric cancer.
  2. To examine a second within-parent factor (i.e., parental perception of child vulnerability) as a predictor or correlate of school reintegration (i.e., school attendance) in children with pediatric cancer.
  3. To develop a statistical model by which relative contributions of each predictor variable (i.e., severity of illness, quality of life, parental stress, parental perception of child vulnerability), as well as their interrelatedness, can be understood in relation to child adjustment. Exploration of each variable's contribution will affect the schematic organization of the model.
  4. To examine demographic variables as covariates in the primary analyses. The variables include: child's age, gender, grade, ethnicity, diagnosis, time since diagnosis, type and duration of treatment, and time since school reintegration.

详细描述

Consent for Child Participation:

STUDY PARTICIPATION:

If you agree to take part in this study, you will complete 3 paper-and-pencil questionnaires that will be used to get information about your health status and overall well being. You will be asked how you are feeling at this time, whether you worry a lot of the time, how often you feel sad, and how physically active you are, such as with walking and running. The study staff is also interested in knowing how well you are keeping up with school activities and how often you attend school. Finally, your doctor will provide information about your illness and describe how it may affect your participation at home or at school.

If you are age 8 or above, it should take about 30-45 minutes to complete the questionnaires. If you are between age 6 and 7, it should take about 10-15 minutes to complete the questionnaires.

Your parent or caregiver may be present while you complete your questionnaires. However, you are encouraged you to give your own answers. The questionnaires may be completed in The Children's Cancer Hospital clinic or elsewhere, and a research assistant will assist you, if you need help.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 6 and 17 years diagnosed with, and treated for, any type of cancer
  • Children enrolled in grades K through 12
  • Children who have actively participated in community or private school during the 2006-2007 academic year
  • Children who have experienced a period of absence from community or private school of at least two consecutive months as a result of medical treatment prior to school reintegration
  • Children who have fully reintegrated as a full-time student within the past 1-3 years
  • Parents and children who are either English- or Spanish-speaking and are able to read in either or both languages
  • Medical staff (i.e., physicians, nurse practitioners) involved in the children's medical decision-making

排除标准

  • Children and/or parents diagnosed and/or identified as having mental retardation (IQ < 70) with concomitant adaptive behavior deficits or classified as having any type of Pervasive Developmental Disorder (PDD)
  • Children and/or parents who speak a language other than English or Spanish
  • Participant (e.g., parent or child) unwillingness to participate in any capacity

结局指标

主要结局

Severity of Illness [using The Severity of Illness Scale (SOIS)]

时间窗: Completion of scale by medical staff, approximately 2-5 minutes

Quality of Life [using The Pediatric Quality of Life (PedsQL)]

时间窗: Questionnaire, approximately 45 minutes to one hour for parent or non-parent caregivers to complete their measures

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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