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Efficacy and cost-utility of the eHealth application ‘Oncokompas’, supporting patients with incurable cancer in finding optimal palliative care, tailored to their quality of life and personal preferences: a study protocol of a randomized controlled trial
BMC Palliative Care ( IF 2.5 ) Pub Date : 2019-10-23 , DOI: 10.1186/s12904-019-0468-8
Anouk S. Schuit , Karen Holtmaat , Nienke Hooghiemstra , Femke Jansen , Birgit I. Lissenberg-Witte , Veerle M. H. Coupé , Myra E. van Linde , Annemarie Becker-Commissaris , Jaap C. Reijneveld , Josée M. Zijlstra , Dirkje W. Sommeijer , Simone E. J. Eerenstein , Irma M. Verdonck-de Leeuw

Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas compared to care as usual. 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient’s knowledge, skills and confidence to manage his or her own health and healthcare. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. This study will result in knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. Netherlands Trial Register identifier: NTR 7494 . Registered on 24 September 2018.

中文翻译:

eHealth应用程序“ Oncokompas”的功效和成本效用,支持顽固性癌症患者寻找最佳姑息治疗,并根据其生活质量和个人喜好量身定制:一项随机对照试验的研究方案

不可治愈的癌症患者由于其疾病和治疗方法而不得不应对多种症状,从而影响其生活质量。如今,患者有望在管理自己的健康和保健方面发挥积极作用。Oncokompas是一种eHealth自我管理应用程序,旨在根据患者的生活质量和个人喜好为患者寻找最佳的姑息治疗提供支持。将进行一项随机对照试验,以确定与通常的护理相比,Oncokompas的功效和成本效益。包括136例患有不可治愈的肺癌,乳腺癌,结肠直肠癌和头颈癌,淋巴瘤和神经胶质瘤的成年患者。符合条件的患者没有治疗选择,并且预后至少三个月。将患者随机分配至干预组或对照组。干预组可以像往常一样直接获得Oncokompas的治疗,而等候名单控制组则像往常一样获得护理,并且在三个月后将可以访问Oncokompas。主要结果指标是患者激活,可以描述为患者掌握自己的健康和保健知识,技能和信心。次要结果指标包括自我效能感,与健康相关的生活质量和费用。测量将在基线,随机化后两周和基线测量后三个月进行评估。这项研究将导致对不可治愈的癌症患者中Oncokompas的功效和成本效用的了解。而且,从社会和医疗保健的角度来看,姑息治疗的需求和费用中将产生更多的知识。荷兰审判注册标识符:NTR 7494。2018年9月24日注册。
更新日期:2019-10-23
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