EXERCISE--AN INTERVENTION FOR FATIGUE IN CANCER PATIENTS

锻炼——癌症患者疲劳的干预措施

• 批准号: 2822836
• 负责人: MARYLIN J DODD
• 金额: $ 36.33万
• 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/2822836
• 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）的患者最常见和致残的症状。 初步研究已经报道了运动对疲劳和相关变量的益处，但没有研究过运动计划的时间与CTX过程的关系。 这项随机临床试验（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个性化运动训练计划。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存在与活动水平，身体健康，睡眠障碍和抑郁症的干预和不干预的疲劳相关变量的差异。 综合疲劳模型1为拟议研究提供了框架。该样本将包括219名患有乳腺癌、结肠直肠癌或前列腺癌的患者，他们正在开始第一个疗程的CTX治疗。该单盲RCT涉及在三个主要数据收集点评估的三个组：基线（T1）、CTX完成（T2）和研究结束（T3）。 第1组（EE）接受干预直至CTX完成和研究结束。 第2组（CE）接受标准护理直至完成CTX，然后接受干预直至研究结束。 第3组（CC）接受标准治疗，直至CTX完成和研究结束。 将根据癌症诊断对样本进行分层。 当在T2或T3时比较各组时，将使用ANCOVA和因变量的基线校正评分。 需要对运动作为自我护理干预进行研究，以便确定运动的频率，强度，持续时间和时间。 这项研究的结果将大大有助于建立这一知识库。