Brandt Å, Pilegaard M S, Oestergaard L G, Lindahl-Jacobsen L, Sørensen J, Johnsen A T, la Cour K
The National Board of Social Services, 5000, Odense C, Denmark.
The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, Department of Public Health, University of Southern Denmark, 5000, Odense C, Denmark.
BMC Palliat Care. 2016 Jan 22;15:10. doi: 10.1186/s12904-016-0084-9.
During the past decade an increasing number of people live with advanced cancer mainly due to improved medical treatment. Research has shown that many people with advanced cancer have problems with everyday activities, which have negative impact on their quality of life, and that they spend a considerable part of their time at home. Still, research on interventions to support the performance of and participation in everyday activities is only scarcely available. Therefore, the occupational therapy-based "Cancer Home-Life Intervention" consisting of tailored adaptive interventions applied in the participant's home environment was developed. The objective of this study is to examine the effectiveness and cost-effectiveness of the Cancer Home-Life Intervention compared to usual care on the performance of and participation in everyday activities and quality of life in people with advanced cancer living at home.
The study is a randomised, controlled trial (RCT) including an economic evaluation. The required sample size of 272 adults living at home will be recruited from outpatient clinics at two Danish hospitals. They should be diagnosed with cancer; evaluated incurable by the responsible oncologist; and with a functional level 1-2 on the WHO performance scale. The primary outcome is the quality of performance of activities of daily living. Secondary outcomes are problems with prioritised everyday activities; autonomy and participation; and health-related quality of life. Participants are randomly assigned to: a) The Cancer Home-Life Intervention in addition to usual care, and b) Usual care alone.
The trial will show whether the Cancer Home-Life Intervention provides better support for people with advanced cancer living at home in performing and participating in everyday activities, and whether it contributes to their health-related quality of life. The economic evaluation alongside the RCT will show if the Cancer Home-Life Intervention is cost-effective. The trial will also show the acceptability of the intervention to the target group, and whether subgroups of participants will benefit more than others.
ClinicalTrials.gov Identifier NCT02356627. Registered 02/02/2015.
在过去十年中，主要由于医疗水平的提高，越来越多的人患有晚期癌症。研究表明，许多晚期癌症患者在日常活动中存在问题，这对他们的生活质量产生了负面影响，并且他们大部分时间都待在家里。然而，关于支持日常活动表现和参与的干预措施的研究却很少。因此，开发了基于职业疗法的“癌症家庭生活干预”，包括在参与者家中环境中应用的量身定制的适应性干预措施。本研究的目的是检验与常规护理相比，癌症家庭生活干预对居家晚期癌症患者日常活动表现、参与度和生活质量的有效性和成本效益。
该研究是一项随机对照试验（RCT），包括经济评估。将从丹麦两家医院的门诊招募272名居家成年人作为所需样本量。他们应被诊断患有癌症；经负责的肿瘤学家评估为无法治愈；且在世卫组织表现量表上的功能水平为1-2级。主要结局是日常生活活动的表现质量。次要结局是优先日常活动中的问题；自主性和参与度；以及与健康相关的生活质量。参与者被随机分配到：a）除常规护理外的癌症家庭生活干预组，和b）仅接受常规护理组。
该试验将表明癌症家庭生活干预是否能为居家晚期癌症患者在进行和参与日常活动方面提供更好的支持，以及它是否有助于提高他们与健康相关的生活质量。与RCT同时进行的经济评估将表明癌症家庭生活干预是否具有成本效益。该试验还将表明干预措施对目标群体的可接受性，以及参与者的亚组是否比其他亚组受益更多。
ClinicalTrials.gov标识符NCT02356627。于2015年2月2日注册。
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