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临床试验/NCT05073848
NCT05073848招募中不适用

Relationships Between Physical Activity and Different Measures of Fatigue in Cancer Survivors

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Physical Activity measure by Actigraph device

研究概览

简要总结

This is an investigation of possible relationships between daily physical activity (PA) and different measurements of fatigue in cancer survivors participating in a cancer exercise program.

详细描述

This is an investigation of possible relationships between daily physical activity (PA) and different measurements of fatigue in cancer survivors participating in a cancer exercise program. Results will inform exercise prescription and timing to best reduce fatigue, as well as methodology for measuring fatigue. Participants will answer several daily questions on fatigue using a smartphone application during the 3 month exercise program and wear a PA monitor for 10 days during the first month and last month of the program.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Be an active participant in the BfitBwell Cancer Exercise Program
  • Criteria for this program include:
  • Adult (>= 18 years old)
  • Being a patient seen at the University of Colorado Cancer Center
  • Currently receiving cancer therapy or be within 6 months of completing cancer therapy
  • Have a signed physician clearance form to participate in an exercise program
  • Have a smartphone (necessary for the EMA assessments)
  • A score of 48 or less on the FACIT-Fatigue (completed during the initial BfitBwell Program assessment)
  • The minimally important difference of the FACIT-Fatigue is 3 points, suggesting that a score of at most 48 indicates the presence of CRF and allows for meaningful change in both directions.

排除标准

  • 未提供

结局指标

主要结局

Physical Activity measure by Actigraph device

时间窗: 3 months

PA will be monitored using commonly used, non-invasive Actigraph devices (Actigraph GT3XP). Data will be collected utilizing methodology similar to that of the National Health and Nutrition Examination Survey (NHANES), in cancer survivors. The collected accelerometry data will be downloaded and analyzed in ActiLife software, calculation the average time spent in moderate-to-vigorous (MVPA) at each assessment period using standard algorithms and cut-points.

10-point Fatigue Scale, Day

时间窗: 3 months

Severity of fatigue experienced over the course of the day, ranked 0-10. How would you rate your fatigue, over the last day, on a scale of 0-10, with 0 being no fatigue and 10 being the worst possible fatigue?

次要结局

  • Physical assessment measures from BfitBwell Program(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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