Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial.,The Lancet Oncology

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Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial.
The Lancet Oncology ( IF 41.6 ) Pub Date : 2019-12-11 , DOI: 10.1016/s1470-2045(19)30675-8
Anja van der Hout ₁ , Cornelia F van Uden-Kraan ₁ , Karen Holtmaat ₁ , Femke Jansen ₂ , Birgit I Lissenberg-Witte ₃ , Grard A P Nieuwenhuijzen ₄ , José A Hardillo ₅ , Robert J Baatenburg de Jong ₅ , Nicolette L Tiren-Verbeet ₆ , Dirkje W Sommeijer ₇ , Koen de Heer ₈ , Cees G Schaar ₉ , Robert-Jan E Sedee ₁₀ , Koop Bosscha ₁₁ , Michiel W M van den Brekel ₁₂ , Japke F Petersen ₁₂ , Matthijs Westerman ₁₃ , Jimmie Honings ₁₄ , Robert P Takes ₁₄ , Ilse Houtenbos ₁₅ , Wim T van den Broek ₁₆ , Remco de Bree ₁₇ , Patricia Jansen ₁₈ , Simone E J Eerenstein ₁₉ , C René Leemans ₂₀ , Josée M Zijlstra ₂₁ , Pim Cuijpers ₂₂ , Lonneke V van de Poll-Franse ₂₃ , Irma M Verdonck-de Leeuw ₂

Affiliation

Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.
Department of Otolaryngology and Head and Neck Surgery, Rotterdam, Netherlands.
Department of Haematology, Erasmus Medical Centre, Rotterdam, Netherlands.
Department of Internal Medicine, Flevoziekenhuis, Almere, Netherlands; Department of Medical Oncology, University of Amsterdam, Amsterdam, Netherlands.
Department of Internal Medicine, Flevoziekenhuis, Almere, Netherlands; Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
Department of Internal Medicine, Gelre ziekenhuis, Apeldoorn, Netherlands.
Department of Otolaryngology, Head and Neck Surgery, Haaglanden MC, The Hague, Netherlands.
Department of Surgery, Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands.
Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Amsterdam, Netherlands.
Department of Hematology, Northwest Clinics, Alkmaar, Netherlands.
Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Medical Center, Nijmegen, Netherlands.
Department of Hematology, Spaarne Gasthuis, Hoofddorp, Netherlands.
Department of Surgery, St Anna Hospital, Geldrop, Netherlands.
Department of Head and Neck Surgical Oncology, Utrecht University Medical Center, Utrecht, Netherlands.
Department of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.
Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Department of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Department of Research, Netherlands Comprehensive Cancer Organisation, Eindhoven, Netherlands; Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Netherlands; Center of Research on Psychological and Somatic Disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.

BACKGROUND Knowledge about the efficacy of behavioural intervention technologies that can be used by cancer survivors independently from a health-care provider is scarce. We aimed to assess the efficacy, reach, and usage of Oncokompas, a web-based eHealth application that supports survivors in self-management by monitoring health-related quality of life (HRQOL) and cancer-generic and tumour-specific symptoms and obtaining tailored feedback with a personalised overview of supportive care options. METHODS In this non-blinded, randomised, controlled trial, we recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma. Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient Reported Outcomes Following Initial Treatment and Long term Evaluation of Survivorship (PROFILES) registry. Participants were randomly assigned (1:1) by an independent researcher to the intervention group (access to Oncokompas) or control group (access to Oncokompas after 6 months), by use of block randomisation (block length of 68), stratified by tumour type. The primary outcome was patient activation (knowledge, skills, and confidence for self-management), assessed at baseline, post-intervention, and 3-month and 6-month follow-up. Linear mixed models (intention-to-treat) were used to assess group differences over time from baseline to 6-month follow-up. The trial is registered in the Netherlands Trial Register, NTR5774 and is completed. FINDINGS Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility were recruited and randomly assigned to the intervention (320) or control group (305). Median follow-up was 6 months (IQR 6-6). Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7 [95% CI -0·8-4·1], p=0·41). INTERPRETATION Oncokompas did not improve the amount of knowledge, skills, and confidence for self-management in cancer survivors. This study contributes to the evidence for the development of tailored strategies for development and implementation of behavioural intervention technologies among cancer survivors. FUNDING Dutch Cancer Society (KWF Kankerbestrijding).

中文翻译：

eHealth应用Oncokompas在支持癌症幸存者症状自我管理和健康相关生活质量方面的作用：一项随机对照试验。

背景技术关于可以由癌症幸存者独立于健康护理提供者使用的行为干预技术的功效的知识很少。我们旨在评估Oncokompas（基于网络的eHealth应用程序）的功效，覆盖范围和使用情况，该应用程序通过监视与健康相关的生活质量（HRQOL），癌基因和肿瘤特有的症状并获得量身定制的方法来支持幸存者进行自我管理提供个性化的支持治疗选择概述的反馈。方法在这项非盲，随机，对照试验中，我们招募了在荷兰的14家医院接受过头颈部癌，结肠直肠癌，乳腺癌，霍奇金淋巴瘤或非霍奇金淋巴瘤治疗的患者。成年幸存者（年龄≥18岁）通过荷兰癌症登记中心（NCR）招募，并由其治疗医师通过初始治疗和长期生存率评估（PROFILES）登记后的患者报告结果邀请。通过采用分组随机分组（分组长度为68），由独立研究人员将参与者随机分配（1：1）至干预组（进入Oncokompas）或对照组（进入6个月后进入Oncokompas），按肿瘤类型分层。主要结果是在基线，干预后以及3个月和6个月的随访中评估患者的激活程度（知识，技能和自我管理信心）。线性混合模型（意向治疗）用于评估从基线到6个月随访期间随时间变化的组别差异。该审判已在荷兰审判登记簿NTR5774中注册，并已完成。结果在2016年10月12日至2018年5月24日之间，招募了2953位合格的存活者中的625位（21％），并将其随机分配至干预措施（320）或对照组（305）。中位随访时间为6个月（IQR 6-6）。干预组和对照组之间的患者激活时间之间无显着差异（6个月随访时差异1·7 [95％CI -0·8-4·1]，p = 0·41）。解释Oncokompas不能提高癌症幸存者自我管理的知识，技能和信心。这项研究为开发针对癌症幸存者的行为干预技术的量身定制策略提供了证据。资助荷兰癌症协会（KWF Kankerbestrijding）。

更新日期：2020-01-04

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