跳至主要内容
临床试验/NCT05704790
NCT05704790进行中(未招募)不适用

Feasibility and Acceptability of Brief, Telehealth Cognitive Compensatory Training for Children Treated for Pediatric Cancer

University of Michigan Rogel Cancer Center2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
26
试验地点
2
主要终点
Determining satisfaction and perceived benefit from study intervention based off of change in results from the BRIEF-2 questionnaire from baseline to 6 weeks post trial entry

研究概览

简要总结

This pilot study will be a prospective, single arm study to investigate the feasibility and acceptability of a brief, telehealth, cognitive compensatory training intervention for children with a history of pediatric cancer at the University of Michigan. Study aims to enroll 10 children with a history of treatment for pediatric cancer, along with their caregiver.

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
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient between the ages of 8 and 18
  • Patient has a history of pediatric cancer
  • Patient is at least 6 months posttreatment completion
  • Patient and caregiver are fluent in English, as intervention materials are only available in English at this time.
  • Patient demonstrates deficits in attention and/or executive functioning as evidenced by either (a) performance below one standard deviation on at least one cognitive measure of attention or executive functioning, such as on the Conners Continuous Performance Test (CPT-3), Trail making Test A & B, Children's Category Test (CCT), and Wisconsin Card Sorting Test (WCST) and/or (b) executive functioning and attention problems are identified during screening with the research assistant.

排除标准

  • Patient has a history of treatment for a pediatric brain tumor
  • Patient has a history of traumatic brain injury or seizures
  • Patient has a history of a developmental disorder (i.e., autism, intellectual disability), behavioral disorder (i.e., oppositional defiant disorder, conduct disorder), or mood disorder (i.e., disruptive mood dysregulation disorder) that would negatively interfere with patient's participation in the intervention.

结局指标

主要结局

Determining satisfaction and perceived benefit from study intervention based off of change in results from the BRIEF-2 questionnaire from baseline to 6 weeks post trial entry

时间窗: 6 weeks from trial entry

Completion of Study Questionnaire, BRIEF-2, at time of enrollment at after intervention completion.

Determining satisfaction and perceived benefit from study intervention based off of change in results from the Conners 3 questionnaire from baseline to 6 weeks post trial entry

时间窗: 6 weeks from trial entry

Completion of Study Questionnaire, Conners 3, at time of enrollment at after intervention completion.

Determining satisfaction and perceived benefit from study intervention based off of change in results from the SMALSI-2 questionnaire from baseline to 6 weeks post trial entry

时间窗: 6 weeks from trial entry

Completion of Study Questionnaire, SMALSI-2, at time of enrollment at after intervention completion.

Determining satisfaction and perceived benefit from study intervention based off of change in results from the SPSI-R questionnaire from baseline to 6 weeks post trial entry

时间窗: 6 weeks from trial entry

Completion of Study Questionnaires, SPSI-R , at time of enrollment at after intervention completion.

Determining satisfaction and perceived benefit from study intervention based off of change in results from the PKEQ questionnaire from baseline to 6 weeks post trial entry

时间窗: 6 weeks from trial entry

Completion of Study Questionnaires, PKEQ, at time of enrollment at after intervention completion.

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 (2)

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