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临床试验/NCT03132948
NCT03132948暂停不适用

Physical Activity and Quality of Life in Pediatric Patients With Acute Lymphoblastic Leukemia Receiving Maintenance Chemotherapy

Connecticut Children's Medical Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年11月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
25
试验地点
1
主要终点
Quality of Life Outcomes

研究概览

简要总结

The purpose of the study is to evaluate the impact of exercise on physical activity levels and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy.

详细描述

Health-related quality of life is an important outcome of cancer treatment which encompasses physical, psychological, social, and functional well-being. In addition, quality of life includes one's overall ability to become a productive member of society and achieve personal fulfillment. Treatment of pediatric cancer is a highly stressful experience which can be challenging and disruptive to the lives of children and their families. Pediatric oncology patients receiving chemotherapy often experience a decline in quality of life due to decreased activity, fatigue, and psychological distress such as depression or anxiety when compared to healthy individuals. Preliminary data suggests that there is an association between physical activity and quality of life. Exercise has been show to improve mood, increase energy levels, and reduce stress. Although more research and clinical resources have been given to the effects of exercise on quality of life among adult cancer patients, there is a lack of research in these areas among children with cancer. The investigators know little about whether children with cancer would benefit from exercise.

The investigators have added a blood sample for biomarkers. Research in adult cancer patients have shown an association between different biomarkers and sleep quality which suggests that regulation of certain biomarkers may be affected through exercise in adults. Measures of biomarkers may provide insight into potential mediators between PA, sleep quality, or fatigue levels.

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

  • Pediatric oncology patients with ALL in the maintenance phase of chemotherapy during the time of study
  • Ages 8-18 years of either gender (age limits due to reliability and validity of outcome assessment surveys)
  • Have no documented or observable psychiatric or neurological disorders that would interfere with study participation
  • Capable of speaking and reading English
  • Having no contraindications to participate in moderate physical exercise as determined by the research staff and the patient's pediatric oncologist
  • Currently living with their parents/legal guardians
  • Consent obtained from legal guardians and assent obtained from patients to participate in the study

排除标准

  • Not a pediatric oncology patient with ALL in maintenance
  • Not receiving chemotherapy during the time of study
  • Age less than 8 years or greater than 18 years
  • Not English-speaking Since not all outcome measures have been validated in Spanish and other languages, only English-speaking patients will be included.

研究组 & 干预措施

Physical Activity

Experimental

Single arm study where patients choose from physical activities after baseline assessment by PT. Activities include the following: Nintendo WII fit console, Xbox Kinect fit console and other sport activities.

干预措施: Physical Activity (Behavioral)

结局指标

主要结局

Quality of Life Outcomes

时间窗: 1 year

PedsQL

次要结局

  • Fatigue(1 year)
  • Physical Activity(1 year)
  • Sleep(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Orsey

Hematologist/Oncologist

Connecticut Children's Medical Center

研究点 (1)

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