BACKGROUND Disturbances in bodily well-being represent one key source of suffering and impairment related to cancer. There is growing evidence that body psychotherapy (BPT) is efficacious for the treatment of various mental disorders. However, with regard to cancer patients, evidence is scarce. The aims of this project are to evaluate whether bodily disturbances in post-treatment cancer patients can be improved by group BPT, and to estimate the efficacy of intermittent smartphone-triggered bodily interventions. METHODS The project is a bi-center study with two participating centers in Switzerland, applying a pre-post convergent parallel design of a weekly group BPT using a waiting-period comparator, including a nested RCT during the group BPT phase. During the BPT phase, either a smartphone-triggered bodily intervention or a smartphone-triggered control intervention is provided at random over 5 consecutive weeks, on 6 days weekly. Patients who had received curatively intended treatment for any malignant neoplasm (treatment being completed ≥3 months) and are suffering from bodily disturbances are screened to assess eligibility. Sample size estimation is based on an a priori power analysis. We plan to include a total of N = 88 subjects, aiming at at least 52 completers. Patients are surveyed three times (baseline assessment (T0), pre- (T1) and post-intervention assessment (T2)), and on a daily basis along BPT during five consecutive weeks. The primary outcome, bodily disturbances, is assessed using the 'Body Image Scale'(BIS). For the secondary outcomes standardized questionnaires are used to assess changes in experience of presence and vitality, mood, body mindfulness, somatic symptoms and somatic symptom disorder, quality of life, anxiety, and depression including suicidal tendency, vitality and mental health, as well as group cohesion. Using semi standardized interviews (at T0 and T2), we aim to explore the relation of BPT with bodily disturbances and body image in post-treatment cancer patients, as well as the acceptance and burden of the intervention. DISCUSSION The proposed study has strong potential benefits for cancer patients, as it may pave the way for new therapeutic approaches to treat bodily disturbances, which persist despite curative tumor therapy. These may considerably improve patients' biopsychosocial well-being and quality of life. TRIAL REGISTRATION ClinicalTrials.gov NCT03707548 (registered 9 October 2018; retrospectively registered).

中文翻译：

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一项基于团体的身体心理治疗的临床试验，旨在通过结合随机控制的智能手机触发的身体干预措施（KPTK）来改善治疗后癌症患者的身体不适：研究方案。

背景技术对身体健康的干扰是与癌症有关的痛苦和损害的一种重要来源。越来越多的证据表明，身体心理治疗（BPT）可有效治疗各种精神疾病。但是，关于癌症患者，证据很少。该项目的目的是评估BPT组是否可以改善治疗后癌症患者的身体不适，并评估间歇性智能手机触发的身体干预的有效性。方法该项目是一个双中心研究，在瑞士有两个参与中心，采用等待期比较器对每周BPT组进行事前收敛后并行设计，其中包括BPT组中的嵌套RCT。在BPT阶段，每周连续5天（每周6天）随机提供智能手机触发的身体干预或智能手机触发的控制干预。筛选接受过恶性肿瘤治愈性治疗（治疗≥3个月）并且患有身体疾病的患者，以评估其资格。样本大小估计基于先验功率分析。我们计划总共包含N = 88个科目，以至少52名完成者为目标。对患者进行了3次调查（基线评估（T0），干预前（T1）和干预后评估（T2）），并连续5周每天进行一次BPT检查。主要结果是人为干扰，使用“身体影像量表”（BIS）进行评估。对于次要结果，使用标准化问卷调查评估存在和活力，情绪，身体正念，躯体症状和躯体症状紊乱，生活质量，焦虑和抑郁（包括自杀倾向，活力和心理健康）以及以下方面的经历变化：群体凝聚力。我们使用半标准化访谈（在T0和T2），旨在探讨BPT与癌症治疗后患者身体不适和身体形象的关系，以及干预措施的接受程度和负担。讨论拟议的研究对癌症患者具有强大的潜在益处，因为它可能为治疗身体疾病的新治疗方法铺平道路，尽管治疗性肿瘤治疗仍然存在。这些可以大大改善患者的生物心理健康状况和生活质量。