Impact of an Intervention Combining Self-care and Hypnosis on the Well-being of Cancer Patients and Their Partners
- Conditions
- Non-Metastatic Neoplasm
- Interventions
- Behavioral: Self-hypnosis + Self-care
- Registration Number
- NCT03144154
- Lead Sponsor
- University of Liege
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
Not provided
Psychiatric disorders, such as dementia, psychosis or delirium, that do not allow to participate in a group intervention or to complete the evaluations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group : Hypnosis-based intervention Self-hypnosis + Self-care Groupal intervention combining self-care techniques and self-hypnosis exercises
- Primary Outcome Measures
Name Time Method Change in Cancer-Related Fatigue 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 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)
- Secondary Outcome Measures
Name Time Method Change in partners' well-being - Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI) Anxiety and depression of the partners, measured with the HADS.
Change in fear of recurrence T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) Fear that cancer could return. Measured with the Fear of Cancer Recurence Inventory
Change in emotion regulation T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) The way people deal with their emotions. Measured with one questionnaire (Cognitive Emotion Regulation Questionnaire) and a smartphone application asking participants about their daily emotion and how they deal with it. The application is used during 9 days at each measurement time.
Change in attentional bias towards threat T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) Attentional bias toward emotional information especially negative ones. It is linked with anxiety and will be measured by an computerized task.
Change in the quality of the conjugal relationship T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) Communication about cancer and dyadic coping, measured with questionnaires (Couples' Illness Communication Scale ; Dyadic Coping Inventory). The two partners will complete these questionnaires.
Trial Locations
- Locations (1)
University Hospital of Liege
🇧🇪Liege, Belgium