Bäuerle Alexander, Martus Peter, Erim Yesim, Schug Caterina, Heinen Jana, Krakowczyk Julia Barbara, Steinbach Jasmin, Damerau Mirjam, Bethge Wolfgang, Dinkel Andreas, Dries Sebastian, Mehnert-Theuerkauf Anja, Neumann Anja, Schadendorf Dirk, Tewes Mitra, Wiltink Jörg, Wünsch Alexander, Zipfel Stephan, Graf Johanna, Teufel Martin
Clinic for Psychosomatic Medicine and Psychotherapy, LVR-University Hospital, University of Duisburg-Essen, Essen, Germany.
Comprehensive Cancer Center (CCC), University Hospital Essen, Essen, Germany.
BMJ Open. 2022 Jun 1;12(6):e056973. doi: 10.1136/bmjopen-2021-056973.
Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint).
The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18-65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate.
The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations.
German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.
许多癌症患者经历着严重的心理困扰，但由于各种障碍，他们中很少有人能获得心理肿瘤学支持。电子心理健康干预试图克服其中一些障碍以及医疗服务的局限性，使癌症患者能够更好地应对心理困扰。在本拟进行的试验中，我们旨在评估基于手册的电子心理健康干预“让它训练——肿瘤学中基于正念和技能的痛苦减轻”的疗效和成本效益。“让它训练”是一种基于网络的自我引导式心理肿瘤学干预，包含认知行为疗法、基于正念的减压疗法以及接纳与承诺疗法的元素。该训练在4个月的时间里为患者提供支持。我们预计“让它训练”在完成干预后（T1，主要终点）减轻痛苦方面优于常规优化治疗（TAU - O）。
本研究为一项多中心、前瞻性、随机对照验证性干预试验，设有两个平行组。拟进行的试验包含四个不同的测量时间点：随机分组前的基线评估、治疗后评估以及3个月和6个月的随访评估。我们将纳入在过去12个月内确诊癌症、处于根治性治疗阶段、年龄在18 - 65岁之间、已签署知情同意书且至少1周内自我感知心理困扰程度较高（医院焦虑抑郁量表≥13）的患者。患者将被随机分为两组（“让它训练”组与TAU - O组）。目标是招募600名癌症患者，并将556名纳入意向性分析。一旦完成干预（T1），主要终点即痛苦程度将使用基线调整后的协方差分析进行分析，将研究组作为二元因素，基线作为连续测量值，研究中心作为额外的分类协变量。
埃森医学院伦理委员会已批准本研究（21 - 10076 - BO）。研究结果将发表在同行评审期刊、会议报告、项目网站以及自助组织中。
德国临床试验注册中心（DRKS）；DRKS编号：DRKS00025213。
