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一项针对结直肠癌幸存者的远程生活方式干预的随机对照试验(“CanChange”):研究方案。

A randomised controlled trial of a tele-based lifestyle intervention for colorectal cancer survivors ('CanChange'): study protocol.

作者信息

Hawkes Anna L, Pakenham Kenneth I, Courneya Kerry S, Gollschewski Sara, Baade Peter, Gordon Louisa G, Lynch Brigid M, Aitken Joanne F, Chambers Suzanne K

机构信息

Viertel Centre for Research in Cancer Control, Cancer Council Queensland, Brisbane, Australia.

出版信息

BMC Cancer. 2009 Aug 18;9:286. doi: 10.1186/1471-2407-9-286.

Abstract

BACKGROUND

Colorectal cancer survivors may suffer from a range of ongoing psychosocial and physical problems that negatively impact on quality of life. This paper presents the study protocol for a novel telephone-delivered intervention to improve lifestyle factors and health outcomes for colorectal cancer survivors.

METHODS/DESIGN: Approximately 350 recently diagnosed colorectal cancer survivors will be recruited through the Queensland Cancer Registry and randomised to the intervention or control condition. The intervention focuses on symptom management, lifestyle and psychosocial support to assist participants to make improvements in lifestyle factors (physical activity, healthy diet, weight management, and smoking cessation) and health outcomes. Participants will receive up to 11 telephone-delivered sessions over a 6 month period from a qualified health professional or 'health coach'. Data collection will occur at baseline (Time 1), post-intervention or six months follow-up (Time 2), and at 12 months follow-up for longer term effects (Time 3). Primary outcome measures will include physical activity, cancer-related fatigue and quality of life. A cost-effective analysis of the costs and outcomes for survivors in the intervention and control conditions will be conducted from the perspective of health care costs to the government.

DISCUSSION

The study will provide valuable information about an innovative intervention to improve lifestyle factors and health outcomes for colorectal cancer survivors.

TRIAL REGISTRATION

ACTRN12608000399392.

摘要

背景

结直肠癌幸存者可能会面临一系列持续存在的心理社会和身体问题,这些问题会对生活质量产生负面影响。本文介绍了一项新颖的电话干预研究方案,旨在改善结直肠癌幸存者的生活方式因素和健康状况。

方法/设计:将通过昆士兰癌症登记处招募约350名近期确诊的结直肠癌幸存者,并随机分为干预组或对照组。干预措施聚焦于症状管理、生活方式及心理社会支持,以帮助参与者改善生活方式因素(身体活动、健康饮食、体重管理和戒烟)及健康状况。参与者将在6个月内从一名合格的健康专业人员或“健康教练”那里接受多达11次电话干预。数据收集将在基线(时间1)、干预后或6个月随访时(时间2)以及12个月随访时进行,以评估长期效果(时间3)。主要结局指标将包括身体活动、癌症相关疲劳和生活质量。将从政府医疗保健成本的角度对干预组和对照组幸存者的成本及结局进行成本效益分析。

讨论

该研究将为改善结直肠癌幸存者生活方式因素和健康状况的创新干预措施提供有价值的信息。

试验注册

ACTRN12608000399392。

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