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临床试验/NCT04423939
NCT04423939已完成不适用

ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients

Duke University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2020年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)

研究概览

简要总结

This is a research study to develop and test a novel protocol to reduce physical and psychological vulnerabilities that contribute to treatment intolerance and treatment-related morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the participant enrolls in this study, they will be asked to participate in acceptance and commitment therapy (ACT) as well as complete in-person physical function tests and a cognitive test. They will also receive training on how to use iOS devices (e.g. iPad, iPhone) and activity trackers (e.g. Apple Watch), which will be provided to them during the duration of study participation. The study team will ask you to complete multiple surveys about emotional and cognitive function, diet and social support, and ask the participant to provide feedback about the treatment (e.g., what they liked or did not like). The study team will also ask the participant to provide stool samples for analysis of the bacteria in intestines, skin surface swabs for analysis of the bacteria on skin and blood samples for analysis of biomarkers and metabolites. Biomarkers and metabolites are molecular and cellular parts that deal with genetic makeup, like DNA, RNA, protein, and/or other naturally occurring substances that may be associated with transplant outcomes. Participants can expect to be enrolled in this study for 3 years.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over the age of 18
  • Undergoing allogeneic HCT for any cancer or noncancer illness
  • English speaking
  • Has a caregiver willing to participate
  • Over the age of 18
  • English speaking

排除标准

  • Under the age of 18
  • Non-English speaking
  • Has a caregiver unwilling to participate

结局指标

主要结局

Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)

时间窗: Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT

The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Hospital Length of Stay, as Measured by Medical Record Review

时间窗: Up to Day 90

Hospital length of stay in days

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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