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临床试验/NCT03144154
NCT03144154已完成不适用

Impact of an Intervention Combining Self-care and Hypnosis on the Well-being of Cancer Patients and Their Partners

University of Liege2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
Change in Cancer-Related Fatigue

研究概览

简要总结

Hypnosis-based interventions are starting to be tested in order to improve emotional distress and fatigue of cancer patients. However, most of these studies only include breast cancer patients and do no measure long-term effects of such interventions.

Our randomized controlled trial aims to propose to 116 post-treatment cancer patients (all tumour localisations accepted) an 8-week groupal intervention combining hypnosis and self-care techniques.

Primary outcomes (emotion regulation, emotional distress, fatigue) and secondary outcomes (sleep difficulties, fear of recurrence, attentional bias, conjugal communication) will be investigated at 3 measurement times: before the intervention (T1), 3 months later (T2 - right after the intervention of the experimental group, and right before the intervention of the control group) and again 3 months later (T3 - after the intervention of the control group). Some questionnaires, two relaxation tasks, an attentional task, an actigraph and a smartphone application will be used to collect data. The indirect impact of the intervention on participants' partners will also be measured by questionnaires (emotional distress, conjugal communication).

Data collection has started on March 2017. Our results should bring new knowledge about the efficacy of an hypnosis-based intervention to improve fatigue and well-being in cancer patients, which are often under-diagnosed and under-treated, but also about the indirect efficacy to improve partners' well-being. Those results might contribute to spread this kind of inexpensive intervention in oncology settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Psychiatric disorders, such as dementia, psychosis or delirium, that do not allow to participate in a group intervention or to complete the evaluations

结局指标

主要结局

Change in Cancer-Related Fatigue

时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

A sense of tiredness or exhaustion linked with cancer and its treatments, that is not alleviated by sleep. It will be measured with the Multidimensional Fatigue Inventory (MFI-20) and the Insomnia Severity Index (ISI).

Change in emotional distress

时间窗: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

Anxiety + Depression, measured with the Hospital Anxiety and Depression Scale (HADS)

次要结局

  • Change in fear of recurrence(T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up))
  • Change in emotion regulation(T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up))
  • Change in attentional bias towards threat(T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up))
  • Change in the quality of the conjugal relationship(T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up))
  • Change in partners' well-being(- Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabelle Bragard

PhD

University of Liege

研究点 (2)

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