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患者对参与随机运动试验的满意度:随机分组及试验后常规护理运动计划的影响

Patient satisfaction with participation in a randomized exercise trial: effects of randomization and a usual care posttrial exercise program.

作者信息

Courneya Kerry S, Forbes Cynthia C, Trinh Linda, Sellar Christopher M, Friedenreich Christine M, Reiman Tony

机构信息

aFaculty of Physical Education and Recreation, University of Alberta, Edmonton, AB, Canada.

出版信息

Clin Trials. 2013;10(6):959-66. doi: 10.1177/1740774513495985. Epub 2013 Aug 5.

Abstract

BACKGROUND

Participation in an exercise trial is a major commitment for cancer survivors, but few exercise trials have evaluated patient satisfaction with trial participation.

PURPOSE

To examine patient satisfaction with participation in the Healthy Exercise for Lymphoma Patients (HELP) Trial and to explore possible determinants.

METHODS

The HELP Trial randomized 122 lymphoma patients to 12 weeks of supervised aerobic exercise training (AET; n = 60) or to usual care (UC; n = 62), with the option of participating in a 4-week posttrial exercise program. At the 6-month follow-up assessment, participants evaluated their overall trial satisfaction.

RESULTS

Personal satisfaction with trial participation was strongly influenced by group assignment with participants randomized to AET reporting participation to be more rewarding (p < 0.001) and personally useful (p < 0.001) than participants randomized to UC. UC participants who completed the optional 4-week posttrial exercise program reported participation to be more rewarding (p = 0.008) and personally useful (p < 0.001) than UC participants who declined the program.

LIMITATIONS

The study is limited by the lack of a validated measure of participant satisfaction, and the fact that the offer of participation in the posttrial exercise program to the UC group was not randomized.

CONCLUSIONS

Lymphoma patients randomized to UC viewed it as less rewarding and personally useful despite being offered a 4-week posttrial exercise program. UC participants who completed the 4-week program reported personal satisfaction levels similar to the AET group; however, the causal direction of this association is unknown. Researchers should continue to evaluate participant satisfaction in exercise trials.

摘要

背景

参与一项运动试验对癌症幸存者来说是一项重大的投入,但很少有运动试验评估患者对试验参与的满意度。

目的

研究淋巴瘤患者对参与“淋巴瘤患者健康运动(HELP)试验”的满意度,并探索可能的决定因素。

方法

HELP试验将122名淋巴瘤患者随机分为两组,一组接受为期12周的有监督的有氧运动训练(AET;n = 60),另一组接受常规护理(UC;n = 62),患者还可选择参与为期4周的试验后运动计划。在6个月的随访评估中,参与者对他们的总体试验满意度进行了评价。

结果

对试验参与的个人满意度受分组的强烈影响,随机分配到AET组的参与者报告称参与比随机分配到UC组的参与者更有意义(p < 0.001)且对个人更有益(p < 0.001)。完成了可选的4周试验后运动计划的UC组参与者报告称参与比拒绝该计划的UC组参与者更有意义(p = 0.008)且对个人更有益(p < 0.001)。

局限性

该研究受到缺乏经过验证的参与者满意度测量方法的限制,以及向UC组提供试验后运动计划的提议未进行随机分配这一事实的限制。

结论

尽管向UC组提供了为期4周的试验后运动计划,但随机分配到UC组的淋巴瘤患者认为参与该试验的意义和对个人的益处较小。完成了4周计划的UC组参与者报告的个人满意度水平与AET组相似;然而,这种关联的因果方向尚不清楚。研究人员应继续评估运动试验中参与者的满意度。

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