通过向患者教育关于反安慰剂效应来预防化疗不良事件（RENNO 研究）-一项针对胃肠道癌患者的随机对照试验研究方案。
Preventing adverse events of chemotherapy by educating patients about the nocebo effect (RENNO study) - study protocol of a randomized controlled trial with gastrointestinal cancer patients.
机构信息
Department of Oncology, Haematology, Bone Marrow Transplantation with Section Pneumology, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
出版信息
BMC Cancer. 2018 Sep 24;18(1):916. doi: 10.1186/s12885-018-4814-7.
BACKGROUND
Patients undergoing chemotherapy are highly burdened by side effects. These may be caused by the pharmacodynamics of the drug or be driven by psychological factors such as negative expectations or pre-conditioning, which reflect nocebo effects. As such, negative pre-treatment expectations or prior experiences might exacerbate the burden of chemotherapy side effects. Educating patients about this nocebo effect has been put forward as a potential strategy to optimize patients' pre-treatment expectations. In this study, we evaluate whether a briefing about the nocebo effect is efficacious in reducing side effects.
METHODS
In this exploratory study, a total number of n = 100 outpatients with newly diagnosed gastrointestinal cancers are randomized 1:1 to an information session about the nocebo effect (nocebo-education) or an attention control group (ACG) with matching interaction time. Assessments take place before the intervention (T1 pre), post-intervention (T1 post), and 10 days (T2) and 12 weeks (T3) after the initial chemotherapy. The primary outcomes are the patient-rated number and intensity of side effects at 10-days and at 12-weeks follow-up. Secondary outcomes include coping with side effects, tendency to misattribute symptoms, compliance intention, attitude towards the chemotherapy, co-medication to treat side effects and the clinician-rated severity of toxicity. Further analyses are conducted to investigate whether a potential beneficial effect is mediated by a change of expectations before and after the intervention.
DISCUSSION
Informing patients about the nocebo effect might be an innovative and feasible intervention to reduce the burden of side effects and strengthen patients' perceived control over adverse symptoms.
TRIAL REGISTRATION
The trial is registered at the German Clinical Trials Register (ID: DRKS00009501 ; retrospectively registered on March 27, 2018). The first patient was enrolled on September 29, 2015.
背景
接受化疗的患者深受副作用的困扰。这些副作用可能是药物的药效学引起的，也可能是由心理因素引起的，如负面预期或预先条件，这反映了反安慰剂效应。因此，负面的治疗前预期或先前的经历可能会加重化疗副作用的负担。教育患者了解这种反安慰剂效应已被提出作为优化患者治疗前预期的一种潜在策略。在这项研究中，我们评估了关于反安慰剂效应的简介是否能有效减轻副作用。
方法
在这项探索性研究中，总共 100 名新诊断为胃肠道癌症的门诊患者被随机分为 1:1 接受关于反安慰剂效应的信息会议（反安慰剂教育组）或匹配交互时间的对照组（ACG）。评估在干预前（T1 前）、干预后（T1 后）以及初次化疗后 10 天（T2）和 12 周（T3）进行。主要结局是患者在 10 天和 12 周随访时报告的副作用数量和强度。次要结局包括应对副作用、症状归因倾向、依从性意向、对化疗的态度、治疗副作用的合并用药和临床医生评定的毒性严重程度。进一步的分析旨在调查潜在的有益效果是否通过干预前后预期的变化来介导。
讨论
告知患者关于反安慰剂效应可能是一种减轻副作用负担和增强患者对不良反应感知控制的创新且可行的干预措施。
试验注册
该试验在德国临床试验注册处（ID：DRKS00009501；于 2018 年 3 月 27 日追溯注册）。首例患者于 2015 年 9 月 29 日入组。
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