Public Health Department and Sensation and Perception Research Group, GIGA-Consciousness, University of Liège, Liège, Belgium.
Algology-Palliative Care Department, CHU Liège, and Sensation and Perception Research Group, GIGA-Consciousness, University of Liège, Liège, Belgium.
BMC Cancer. 2018 Nov 15;18(1):1113. doi: 10.1186/s12885-018-5046-6.
Cancer has a lot of consequences on patients' quality of life (such as cancer-related fatigue (CRF), sleep difficulties and emotional distress) and on patients' partners and their relationship, such as distress and communication difficulties. These consequences are undertreated, and interventions based on hypnosis often focus on breast cancer patients only. This paper describes the study protocol of a longitudinal randomized controlled trial aiming to assess the efficacy of an 8-week intervention combining hypnosis and self-care to improve cancer patients' CRF, sleep and emotional distress and to indirectly improve their partners' distress.
A power analysis required a total sample of 88 patients. To test the efficacy of the intervention, results of the experimental group receiving the intervention will be compared to those of the control group. Data will be collected by questionnaires, relaxation tasks, an attentional bias task, and everyday life assessments measured at four different times: 1.) before inclusion in the study (baseline); 2.) after the intervention; and 3.) at 4- and 12-month follow-up. Partners' symptoms will also be evaluated with questionnaires at the same measurement times.
There is a growing interest in alternative approaches (such as hypnosis) in addition to standard therapies in oncology settings. The results of this study should be useful for improving knowledge about long-term efficacy of hypnosis-based group interventions for CRF, sleep and distress among all types of cancer patients and their partners, and to better understand the mechanisms of emotional regulation in cancer patients through the attentional bias task.
ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017.
癌症对患者的生活质量（如癌症相关疲劳（CRF）、睡眠困难和情绪困扰）和患者的伴侣及其关系（如困扰和沟通困难）产生了很多影响。这些后果未得到充分治疗，基于催眠的干预措施通常仅针对乳腺癌患者。本文描述了一项纵向随机对照试验的研究方案，旨在评估将催眠与自我保健相结合的 8 周干预措施对改善癌症患者 CRF、睡眠和情绪困扰的疗效，并间接地改善其伴侣的困扰。
一项功效分析需要总共 88 名患者的样本量。为了测试干预措施的效果，实验组接受干预后的结果将与对照组进行比较。数据将通过问卷、放松任务、注意力偏差任务以及日常生活评估收集，这些评估在四个不同时间点进行：1.）研究纳入前（基线）；2.）干预后；3.）4 个月和 12 个月随访时。在相同的测量时间，伴侣的症状也将通过问卷进行评估。
除了肿瘤学领域的标准疗法外，人们对替代方法（如催眠）越来越感兴趣。这项研究的结果对于提高对基于催眠的团体干预对所有类型癌症患者及其伴侣的 CRF、睡眠和困扰的长期疗效的认识应该是有用的，并通过注意力偏差任务更好地了解癌症患者的情绪调节机制。
ClinicalTrials.gov（NCT03144154）。于 2017 年 5 月 1 日进行回顾性注册。
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