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临床试验/NCT00629395
NCT00629395终止不适用

Computerized Cognitive Training for Childhood Cancer Survivors: A Pilot Study

Duke University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2007年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
9
试验地点
2
主要终点
Computer program results

研究概览

简要总结

Specific Aim 1: To assess the feasibility and acceptability of a home-based, computerized attention training program with survivors of central nervous system (CNS) impacting pediatric cancer (e.g. acute lymphocyte leukemia [ALL], brain tumors).

Specific Aim 2: To estimate the effect size of this attention training program with survivors of childhood cancer to determine whether a larger-scale clinical trial is warranted.

详细描述

Pediatric patients meeting initial eligibility criteria will be identified through the databases for each clinic (n = approximately 50 survivors in each clinic). A letter explaining the purpose of the study will then be sent to the parents of these patients. Interested parents will be invited to contact study personnel by phone or email for a thorough review of the study and to schedule a screening appointment.

After obtaining written informed consent and assent (from parents and child, respectively), screening procedures will include administration of an abbreviated intellectual test battery, two working memory tasks, and a computerized attention measure to the survivor. Parents will complete questionnaire measures regarding their child's adaptive, behavioral, emotional, and attentional functioning; follow-up interviewing will be conducted to clarify any potential problems identified on the questionnaires. The entire screening procedure is estimated to take approximately 60 minutes for the survivor and 30-45 minutes for parents. To maximize efficiency, a research assistant will complete testing with the child and a psychologist will explain the questionnaire measures to the parent and conduct any follow-up interviewing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • A T-score greater than the 75th percentile on either the Cognitive Problems/Inattention or the DSM-IV Inattention subscales of the Conners' Parent Rating Scale
  • One or more standard deviations below the mean on the Working Memory Index of the WISC-IV or a Working Memory Index that is one or more standard deviations below the participant's estimated IQ.
  • These criteria are based on the eligibility criteria used in the largest trial to date of psychostimulant methylphenidate (MPH; commonly known as Ritalin) with survivors of childhood cancer.

排除标准

  • Estimated IQ ≤ 70
  • Motor, visual, or auditory handicap that prevents computer use
  • A diagnosis of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), depression, autism, or pervasive developmental disorder (PDD)
  • Insufficient fluency in English.
  • Participants who are currently taking stimulant medications (stable dose for at least 30 days) for attentional difficulties, but who meet inclusion criteria will be allowed to participate.

结局指标

主要结局

Computer program results

时间窗: baseline and study completion

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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