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临床试验/NCT04985409
NCT04985409已完成不适用

Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年10月26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
23
试验地点
2
主要终点
Fitness measured by 6 minute walk test after discharge

研究概览

简要总结

The purpose the research is to obtain preliminary data about the change in fitness from admission to discharge in patients undergoing an Autologous Stem Cell Transplant (ASCT) , assessed by the 6 minute walk test as the primary objective and the SF-36 as the secondary objective. All subjects will wear a Fitbit monitor while admitted for the ASCT to record their daily activity.

详细描述

This study will enroll 20 subjects with a diagnosis of multiple myeloma or lymphoma (10 with each diagnosis) scheduled to undergo ASCT at Cedars-Sinai Medical Center.

After signing the informed consent form, intake data will be collected on all subjects will include age, diagnosis, Karnofsky performance status, and comorbidity index. Subjects will complete an SF-36 questionnaire that assesses their functional and emotional status. Each subject will undergo a 6-minute walk test (6MWT) while wearing a Fitbit monitor to record the number of steps taken. After admission, subjects will be randomly assigned to either the control or intervention group. Subjects in the control arm will receive an activity monitor but the physician, nurse, and patient will not receive any feedback from the device. Patients will be blinded to any data capture from their activity monitor. Participants in the intervention arm will receive an activity monitor and they will receive feedback from the activity tracker and the in-room TV screen. Study participants in this arm will engage with their physicians and nurses around achievement of daily step goals by viewing the in-room TV display of daily step counts on rounds. After discharge, all subjects will again complete the SF-36 questionnaire and perform a 6MWT at a routine clinic visit, within 30 days of the transplant procedure. Descriptive statistics in the form of mean and standard deviation will be used to summarize patient physical activity as measured by 6MWT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

Subjects who are randomized to not get feedback about their activity will not be aware that there is another group that is receiving feedback

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of multiple myeloma or lymphoma with plan to undergo autologous stem cell transplant
  • at least 18 years of age
  • English or Spanish speaking
  • have access to an IOS or Android device
  • able to provide informed consent.

排除标准

  • pre-existing physical limitations which would preclude achievement of the ambulation goals
  • inability to wear the activity monitor
  • Jehovah's Witness patients enrolled in the bloodless transplant program are excluded as they require strict bed rest for long periods of time

结局指标

主要结局

Fitness measured by 6 minute walk test after discharge

时间窗: 3-4 weeks

Standard 6 minute walk test will be performed

次要结局

  • Fitness assessed by SF-36 questionnaire after discharge(3-4 weeks)

研究者

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

Ronald Paquette

Medical Director, Blood and Marrow Transplant Program

Cedars-Sinai Medical Center

研究点 (2)

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