EXERCISE--AN INTERVENTION FOR FATIGUE IN CANCER PATIENTS

锻炼——癌症患者疲劳的干预措施

• 批准号: 6164323
• 负责人: MARYLIN J DODD
• 金额: $ 58.83万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-01 至 2004-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6164323
• 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

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.

疲劳是接受化疗（CTX）的患者最常见和残疾的症状。 初步研究报告了运动对疲劳和相关变量的好处，没有人研究了与CTX相关的锻炼计划的时机。 这项随机临床试验（RCT）的目的是测试系统干预的有效性，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单独量身定制的运动培训计划。第二个目的是评估干预的时机（即在CTX之后）。 第三目的是确定与有或没有干预的活动水平，身体适应性，睡眠障碍和抑郁症的疲劳相关变量是否存在差异。 综合疲劳模型1为拟议的研究提供了框架。该样本将包括219名乳腺癌，结肠直肠癌或前列腺癌的患者，他们正在开始第一疗程的CTX。这个单一的盲人RCT涉及三个组，这些组在三个主要数据收集点进行评估：基线（TL），CTX（T2）的完成和研究结束（T3）。 第1组（EE）接受干预，直至完成CTX并结束研究结束。 第2组（CE）获得标准护理，直到完成CTX，然后再进行研究结束。 第3组（CC）将获得标准护理，直至完成CTX并结束研究结束。 样本将通过癌症诊断进行分层。 当在T2或T3上比较组时，ANCOVA将与因变量的基线调整分数一起使用。 作为自我护理干预措施，需要进行锻炼的研究，以便可以确定练习的频率，强度，持续时间和时间。 这项研究的发现将极大地帮助建立这一知识库。