Grossert Astrid, Urech Corinne, Alder Judith, Gaab Jens, Berger Thomas, Hess Viviane
Medical Oncology, University Hospital Basel, Petersgraben 4, CH, 4031, Basel, Switzerland.
Obstetrics and Gynecology, University Hospital, Spitalstrasse 21, 4031, Basel, Switzerland.
BMC Cancer. 2016 Nov 3;16(1):838. doi: 10.1186/s12885-016-2866-0.
Being diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients.
METHODS/DESIGN: In a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist ("minimal-contact") based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients' characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program.
New technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often comparable to face-to-face interventions. With our study we open this field to the population of newly diagnosed cancer patients. We will not only assess clinical efficacy but also further refine the target population who has the most potential to benefit. An internet-based minimal-contact stress management program might be an attractive, time- and cost-effective way to effectively deliver psychological support to newly diagnosed cancer patients and an opportunity to include those who currently are not reached by conventional support.
ClinicalTrials.gov NCT02289014 .
被诊断患有癌症会导致严重的心理困扰，但大多数新诊断的癌症患者缺乏心理支持。互联网干预克服了寻求面对面支持的许多障碍，并允许在时间和地点上保持独立。我们评估首个针对新诊断的德语癌症患者的基于网络的压力管理干预措施（STREAM：压力-积极-调节）的疗效和可行性。
方法/设计：在一项前瞻性、等待列表对照试验中，120名新诊断的癌症患者将在开始抗癌治疗的12周内入组，并随机分为立即接受（干预组）或延迟接受（对照组）为期8周的基于网络的干预措施。该干预措施由八个模块组成，由一名心理学家根据成熟的压力管理手册每周提供书面反馈（“最低限度接触”），包括可下载的音频文件和练习。本研究的目的是评估与等待列表对照组的患者相比，在生活质量改善（FACT-F）以及焦虑和抑郁减轻（HADS）方面的疗效。120名患者的样本量能够在干预后（T2）以双侧α为0.05和80%的检验效能显示FACT评分中具有临床意义的9分差异。由于这是首个针对德语癌症患者的在线压力管理干预措施，更多描述性结果对于进一步细化最有可能受益的患者群体同样重要，这些患者群体随后将在未来试验中更有针对性地成为目标。这些描述性终点包括：患者特征（癌症类型、治疗类型、社会人口统计学因素）、退出率和退出原因、对该项目的依从性和满意度。
新技术带来了新机遇：最低限度接触的心理干预在几种心理障碍中正成为标准治疗方法，其疗效通常与面对面干预相当。通过我们的研究，我们将这个领域拓展到新诊断的癌症患者群体。我们不仅将评估临床疗效，还将进一步细化最有潜在受益可能的目标人群。基于互联网的最低限度接触压力管理项目可能是一种有吸引力、节省时间和成本的方式，能够有效地为新诊断的癌症患者提供心理支持，并有机会纳入那些目前未得到传统支持的患者。
ClinicalTrials.gov NCT02289014 。
