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Moderate Physical Activity in Helping Patients Recover Physically and Emotionally From Stage II Or Stage III Colorectal Cancer

2010年5月26日 更新者:University of Arizona

The Effect of Moderate Physical Activity on the Physical and Emotional Recovery of Patients With a History of Colorectal Cancer

RATIONALE: Physical activity may prevent or lessen depression and anxiety and improve quality of life and immune function in patients with colorectal cancer.

PURPOSE: This randomized clinical trial is studying how well physical activity helps patients with stage II or stage III colorectal cancer recover from cancer.

研究概览

详细说明

OBJECTIVES:

Primary

  • Assess the effect of moderate physical activity interventions in ameliorating quality of life (as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire) in patients undergoing or who have previously received chemotherapy for stage II or III colorectal cancer.

Secondary

  • Assess the effect of different moderate physical activity interventions in ameliorating depression (as measured by the Beck Depression Inventory) and anxiety (as measured by the Spielberger State-Trait Anxiety Inventory) in these patients.
  • Assess the effect of these interventions on attitudes related to physical activity (as measured by the American Council on Exercise History questionnaire) in these patients.
  • Characterize serum levels and patterns of immune function (cytokines, neutrophils, T cells, B cells, natural killer [NK] cells, and immunoglobulin) in these patients.
  • Correlate serum levels and patterns of immune function (cytokines, neutrophils, T cells, B cells, NK cells, and immunoglobulin) with the patients' physical activity levels.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients participate in individual walking sessions once a week for 8 weeks. The sessions include a fitness-related discussion, warm-up and stretch, 45 minutes of physical activity consisting of walking (progressing in intensity), and a cool-down period.
  • Arm II: Patients participate in a group walking sessions once a week for 8 weeks. The sessions include a fitness-related discussion, warm-up and stretch, 45 minutes of physical activity consisting of walking (progressing in intensity as in arm I), and a cool-down period.
  • Arm III: Patients participate in self-directed physical activity sessions (1½ hours) once a week for 8 weeks. The sessions include warm-up and stretch followed by 45 minutes of progressively intensified physical activity that integrates fundamentals of movement, dance, and exercise principles from established movement methods (i.e., yoga) and a relaxation session/cool-down period.

All patients complete self-reported questionnaires (Spielberger State-Trait Anxiety Inventory, Beck Depression Inventory, Functional Assessment of Cancer Therapy-Colon, and American Council on Exercise History questionnaires). Patients also undergo blood collection at baseline, at 4 weeks, upon completion of study treatment, and at 4 months after completion of study treatment for correlative studies. Blood is examined by flow cytometry for immune function and cytokines.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

研究类型

介入性

注册 (预期的)

45

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

    • Arizona
      • Tucson、Arizona、美国、85724-5024
        • Arizona Cancer Center at University of Arizona Health Sciences Center

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Diagnosis of stage II-III colorectal cancer meeting 1 of the following criteria:

    • Undergoing concurrent chemotherapy
    • Completed chemotherapy within the past 2 years

PATIENT CHARACTERISTICS:

  • No physical or emotional impairment that would limit study compliance
  • No prior or current chronic substance abuse

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

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:支持治疗
  • 分配:随机化

研究衡量的是什么?

主要结果指标

结果测量
Effect of moderate physical activity on quality of life as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire

次要结果测量

结果测量
Effect of moderate physical activity on depression and anxiety as measured by the Beck Depression Inventory and the Spielberger State-Trait Anxiety Inventory
Effect of moderate physical activity on attitudes related to physical activity as measured by the American Council on Exercise History questionnaire
Serum levels and patterns of immune function as measured by cytokine, neutrophil, T cell, B cell, natural killer (NK) cell, and immunoglobulin levels
Correlation of serum levels and patterns of immune function (cytokine, neutrophil, T cell, B cell, NK cell, and immunoglobulin levels) with physical activity levels

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。

调查人员

  • 学习椅:Ana Maria Lopez, MD, MPH、University of Arizona

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

2004年1月1日

初级完成 (实际的)

2006年12月1日

研究完成 (实际的)

2006年12月1日

研究注册日期

首次提交

2006年9月6日

首先提交符合 QC 标准的

2006年9月6日

首次发布 (估计)

2006年9月7日

研究记录更新

最后更新发布 (估计)

2010年5月27日

上次提交的符合 QC 标准的更新

2010年5月26日

最后验证

2006年12月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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