EXERCISE--AN INTERVENTION FOR FATIGUE IN CANCER PATIENTS
EXERCISE--AN INTERVENTION FOR FATIGUE IN CANCER PATIENTS
批准号:
6164323
负责人:
MARYLIN J DODD
金额:
$58.83万
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-05-01 至 2004-02-29
关键词:
body physical activity cancer rehabilitation /care clinical research clinical trials depression drug adverse effect exercise fatigue human subject human therapy evaluation medical rehabilitation related tag neoplasm /cancer chemotherapy personal log /diary photon absorptiometry physical fitness sleep disorders
中文摘要
疲劳是化疗(CTX)患者最常见的致残症状。初步研究报告了运动对疲劳和相关变量的益处,但没有人调查运动计划的时间与CTX病程的关系。本随机临床试验(RCT)的目的是测试系统干预的有效性,即PRO-SELF:疲劳控制计划,包括书面疲劳和运动教学指南以及针对疲劳管理的量身定制的运动训练计划。第二个目的是评估干预的时机(即,在CTX期间与之后)。第三个目的是确定是否有不同的疲劳相关变量的活动水平,身体健康,睡眠障碍和抑郁有和没有干预。综合疲劳模型1为提出的研究提供了框架。样本将包括219名乳腺癌、结肠直肠癌或前列腺癌患者,他们正在开始第一个疗程的CTX治疗。该单盲随机对照试验包括三组患者,在三个主要数据收集点进行评估:基线(Tl)、CTX完成(T2)和研究结束(T3)。组1 (EE)接受干预,直到完成CTX,直到研究结束。组2 (CE)接受标准护理,直到完成CTX,然后进行干预,直到研究结束。组3 (CC)接受标准护理,直到完成CTX并直到研究结束。样本将根据癌症诊断进行分层。当两组在T2或T3进行比较时,ANCOVA将与因变量的基线调整分数一起使用。需要对运动作为一种自我保健干预手段进行研究,以便确定运动的频率、强度、持续时间和时间。本研究的结果将大大有助于建立这一知识库。
英文摘要
Fatigue is the most common and disabling symptom of patients receiving chemotherapy (CTX). Preliminary studies have reported the benefits of exercise on fatigue and related variables, none have investigated the timing of the exercise program in relationship to the course of CTX. The purpose of this randomized clinical trial (RCT) is to test the effectiveness of a systematic intervention, the PRO-SELF: FATIGUE CONTROL Program that includes written fatigue and exercise teaching guides and an individually tailored exercise training program on the management of fatigue. A second purpose is to evaluate the timing of the intervention (i.e., during vs. after CTX). The third purpose is to determine if there are differences in fatigue-related variables of activity level, physical fitness, sleep disturbances and depression with and without the intervention. The Integrated Fatigue Model1 provides the framework for the proposed study. The sample will include 219 individuals with breast, colo-rectal or prostate cancers who are starting their first course of CTX. This single blind RCT involves three groups who are assessed at three major data collection points: baseline (Tl), completion of CTX (T2), and the end of the study (T3). Group 1 (EE) receives the intervention through to the completion of CTX and through to the end of study. Group 2 (CE) receives standard care through to the completion of CTX and then the intervention through to the end of the study. Group 3 (CC) receives standard care through to the completion of CTX and through to the end of the study. The sample will be stratified by cancer diagnoses. When the groups are compared at either T2 or T3, ANCOVA will be used with baseline adjusted scores of the dependent variables. Research is needed on exercise as a self-care intervention so that the frequency, intensity, duration, and timing of the exercises can be determined. The findings of this study will greatly assist in building this knowledge base.
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