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Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial

机译:eHealth自我管理应用程序“ Oncokompas”的功效,成本效用和覆盖范围,可帮助癌症幸存者获得最佳支持治疗:一项随机对照试验的研究方案

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摘要

BACKGROUND: Cancer survivors have to deal with a wide range of physical symptoms, psychological, social and existential concerns, and lifestyle issues related to cancer and its treatment. Therefore, it is essential that they have access to optimal supportive care services. The eHealth self-management application Oncokompas was developed to support cancer survivors with where they need to turn to for advice and guidance, as well as to increase their knowledge on the availability of optimal support. A randomised controlled trial will be conducted to assess the efficacy, cost-utility and reach of Oncokompas as an eHealth self-management application compared with care as usual among cancer survivors. METHODS/DESIGN: Adult cancer survivors diagnosed with breast, colorectal or head and neck cancer or lymphoma who are at 3 months to 5 years since curative treatment will be included. In total, 544 cancer survivors will be randomly assigned to the intervention group or a wait-list control group. The primary outcome measure is patient activation. Secondary outcome measures include self-efficacy, personal control, perceived patient-physician interaction, need for supportive care, mental adjustment to cancer and health-related quality of life. Furthermore, cost-utility outcomes will be assessed. Reach is defined as the percentage of cancer survivors who get access to Oncokompas within the context of this trial. Questionnaires will be administered at baseline, post-intervention and at 3- and 6-month follow-up. DISCUSSION: In this study, we will evaluate the efficacy and cost-utility of Oncokompas among cancer survivors, as well as the reach of Oncokompas. These are essential first steps in the translation of research into practice and contribute to sustainable adoption, implementation and maintenance of an evidence-based Oncokompas. TRIAL REGISTRATION: Netherlands Trial Register identifier: NTR5774 . Registered on 8 March 2016.
机译:背景:癌症幸存者必须处理与癌症及其治疗有关的广泛的身体症状,心理,社会和生存问题以及生活方式问题。因此,他们获得最佳支持治疗服务至关重要。 eHealth自我管理应用程序Oncokompas的开发是为了为癌症幸存者提供支持,他们需要向他们寻求建议和指导,并增加他们对最佳支持的了解。与癌症幸存者通常照料的情况相比,将进行随机对照试验以评估Oncokompas作为eHealth自我管理应用程序的功效,成本效用和覆盖范围。方法/设计:自诊断治疗后3个月至5年内,被诊断患有乳腺癌,结肠直肠癌或头颈癌或淋巴瘤的成年癌症幸存者将包括在内。总共544名癌症幸存者将被随机分配到干预组或候补对照组。主要结果指标是患者的活动。次要结局指标包括自我效能感,个人控制力,患者与医师之间的互动,对支持治疗的需求,对癌症的心理适应以及与健康相关的生活质量。此外,将评估成本-效用结果。触及率定义为在该试验范围内可接触Oncokompas的癌症幸存者的百分比。将在基线,干预后以及3个月和6个月的随访中对问卷进行管理。讨论:在这项研究中,我们将评估癌症幸存者中Oncokompas的功效和成本效用,以及Oncokompas的覆盖范围。这些是将研究转化为实践的重要第一步,有助于以可持续的方式采用,实施和维护基于证据的Oncokompas。试用注册:荷兰试用注册标识:NTR5774。 2016年3月8日注册。

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