Pilegaard Marc Sampedro, Timm Helle, Birkemose Heidi Klit, Dupont Sandra Bakkegaard, Joergensen Dorthe Soested, la Cour Karen
REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital, 5700, Nyborg, Denmark.
The Research Unit for User Perspectives and Community-based Interventions, the Research Group for Occupational Science, Department of Public Health, University of Southern Denmark, 5000, Odense C, Denmark.
Pilot Feasibility Stud. 2022 Apr 20;8(1):86. doi: 10.1186/s40814-022-01038-8.
People with advanced cancer need to balance their resources and energy in order to experience enjoyment and quality of life in the time they have left. A resource-oriented intervention is developed targeting these aspects. The present protocol presents a feasibility study of this resource-oriented intervention in people with advanced cancer.
A feasibility study with a repeated-measurement design without a control group will be conducted at the research clinic of REHPA, the Danish Knowledge Center for Rehabilitation and Palliative Care. Data will be gathered at baseline, during and after a 5-day residential stay, after 6 weeks, during a 2-day follow-up stay and after 12 weeks. In total, 20-25 home-living adults (≥ 18 years) with advanced cancer reporting needs in everyday life will be recruited. The intervention consists of workshops and engagement in physical and creative everyday activities provided by a multidisciplinary team. Outcome measures are quality of life, physical function and fatigue, which will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core-30. Balance in everyday activities will be assessed using the Occupational Balance Questionnaire. Feasibility data will also be collected regarding (1) fidelity, (2) adherence, (3) dose and (4) reach and mechanisms of impact. For exploration of mechanism of impact, participant observations and focus group interviews will be used.
This study presents a new approach in rehabilitation and palliative care aimed at supporting people with advanced cancer; instead of identification of problems, the present resource-oriented palliative rehabilitation intervention will target people's resources, enhancing balance in everyday activities and underpinning enjoyment and quality of life. The results from the feasibility study can inform ways in which to support the everyday life of people with advanced cancer and thus have potential to improve their quality of life. The long-term perspectives are to evaluate the intervention in terms of effect, process and cost-effectiveness. This will provide evidence to adjust the content of rehabilitation and palliative care for this group of people.
NCT04772690 Name of the registry: Balance, Activity and Quality of Life (BAL) Date of registry: February 26, 2021.
晚期癌症患者需要平衡自身资源和精力,以便在剩余时间里体验生活乐趣并提高生活质量。为此开发了一种以资源为导向的干预措施。本方案介绍了针对晚期癌症患者的这种以资源为导向的干预措施的可行性研究。
将在丹麦康复与姑息治疗知识中心REHPA的研究诊所进行一项无对照组的重复测量设计的可行性研究。数据将在基线、5天住院期间及出院后、6周后、2天随访期间及12周后收集。总共将招募20 - 25名日常生活有需求的居家生活的成年晚期癌症患者(≥18岁)。干预措施包括由多学科团队提供的工作坊以及参与日常体育和创意活动。结局指标包括生活质量、身体功能和疲劳,将使用欧洲癌症研究与治疗组织生活质量问卷核心30项进行评估。日常活动平衡将使用职业平衡问卷进行评估。还将收集关于(1)保真度、(2)依从性、(3)剂量以及(4)覆盖范围和影响机制的可行性数据。为探索影响机制,将采用参与者观察和焦点小组访谈。
本研究提出了康复与姑息治疗的一种新方法,旨在支持晚期癌症患者;与识别问题不同,目前这种以资源为导向的姑息康复干预措施将针对患者的资源,增强日常活动的平衡,支持生活乐趣和生活质量。可行性研究结果可为支持晚期癌症患者日常生活的方式提供参考,从而有可能改善他们的生活质量。长期展望是从效果、过程和成本效益方面评估该干预措施。这将为调整针对这一群体的康复与姑息治疗内容提供证据。
NCT04772690 注册机构名称:平衡、活动与生活质量(BAL) 注册日期:2021年2月26日。