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The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older (S-PACT)

2017年9月11日 更新者：UNC Lineberger Comprehensive Cancer Center

A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)

This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.

研究类型

介入性

注册 (实际的)

44

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

61年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Men and women age 65 years and older
  • Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD

  • Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)

    • Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)
    • Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer
  • Moderate to severe fatigue (>4 on BFI)
  • Less than 120 minutes/week of physical activity
  • English speaking
  • Signed IRB approved written informed consent
  • Approval from their treating physician to engage in moderate-intensity physical activity
  • Patient-assessed ability to walk and engage in moderate physical activity
  • Willing and able to meet all study requirements.

Exclusion Criteria:

  • Receiving hormonal therapy for prostate cancer
  • Unable to walk or engage in moderate-intensity physical activity
  • Have BFI≤3.
  • Report more than 120 minutes/week of physical activity

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention
This arm will begin the Walk With Ease program after the completion of chemotherapy.
行为的：轻松行走
Walk With Ease 是关节炎基金会基于证据的步行干预措施，可帮助缓解疲劳和疼痛。 该干预是一项自主计划，可帮助指导参与者进行安全舒适的步调步行计划，最终目标是每周步行 5 天，每天步行 30 分钟。
其他名称：
  • 美国职业摔跤
有源比较器：Wait List Control
The arm will begin the Walk With Ease program three months after completion of chemotherapy.
行为的：轻松行走
Walk With Ease 是关节炎基金会基于证据的步行干预措施，可帮助缓解疲劳和疼痛。 该干预是一项自主计划，可帮助指导参与者进行安全舒适的步调步行计划，最终目标是每周步行 5 天，每天步行 30 分钟。
其他名称：
  • 美国职业摔跤

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
大体时间：Three months
Change in fatigue will be measured using the FACIT-F.
Three months

次要结果测量

结果测量
措施说明
大体时间
To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
大体时间：Three months
This outcome will be measured by the Brief Fatigue Inventory
Three months
To report recruitment and retention in the study at 3 months
大体时间：Three months
Three months
To report recruitment and retention in the study at 6 months
大体时间：Six months
Six months
To measure implementation of and adherence to WWE
大体时间：Six months
Six months
To count the number of adverse events
大体时间：Six months
To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.
Six months
To measure change in engagement of walking over time from baseline to three months.
大体时间：Three Months

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
Three Months
To measure change in physical function over time from baseline to three months.
大体时间：Three Months

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Physical function as measured by SPPB
Three Months
To measure change in quality of life over time from baseline to three months.
大体时间：Three Months

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression.
Three Months
To measure change in self-efficacy over time from baseline to three months.
大体时间：Three Months

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
Three Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UNC Lineberger Comprehensive Cancer Center

合作者

Breast Cancer Research Foundation

调查人员

  • 首席研究员：Hyman B Muss, MD、UNC Lineberger Comprehensive Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年6月1日

初级完成 (实际的)

2017年8月1日

研究完成 (实际的)

2017年8月1日

研究注册日期

首次提交

2014年6月20日

首先提交符合 QC 标准的

2014年7月14日

首次发布 (估计)

2014年7月16日

研究记录更新

最后更新发布 (实际的)

2017年9月12日

上次提交的符合 QC 标准的更新

2017年9月11日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LCCC1402

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