A Hypnosis-based Group Intervention to Improve Quality of Life in Children With Cancer and Their Parents.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in parents' conception of their child's quality of life
研究概览
简要总结
Background: A lot of children with cancer suffer from emotional distress, fatigue and relational difficulties. Their parents are also impacted by the disease: their responsibilities increase and they can feel more distressed and tired. Different psychological interventions designed for ill children and their parents seem to be efficient to improve their social functioning, coping strategies and well-being. However, more research is needed in this field. Hypnosis is often used in paediatric oncology, mostly to decrease procedure-related pain and distress. It has been used efficiently to improve the well-being of adults with cancer. This paper describes a pilot study designed to assess the feasibility and interest of a group intervention combining self-care and hypnosis for children with cancer and their parents, and a quasi-experimental protocol aimed at assessing the efficacy of this group intervention to improve the quality of life of children and their parents.
Methods: Our pilot study showed that our intervention was feasible and positive for the participants. To test the efficacy of the intervention, two groups will be set up: one with children with cancer and their interested siblings, and one with their parents. Data will be collected for each group before and after the intervention by questionnaires and a semi-structured interview.
Discussion: There is a growing interest in hypnosis in oncology settings. The results of this study should improve knowledge about the efficacy of a group intervention combining self-care and hypnosis to improve quality of life of children with cancer and their family.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and their siblings:
- •To be 8 to 18 year-old
- •To suffer from cancer (all localisations, stage and treatments accepted) or to have a sibling who suffer from cancer
- •To speak french
- •To have a child who suffer from cancer
- •To speak french
排除标准
- 未提供
结局指标
主要结局
Change in parents' conception of their child's quality of life
时间窗: T0 (before the intervention), T1 (right after the intervention : 6 months later)
Parents' hetero-evaluation of the child's quality of life. Measured with the Parental version of the Pediatric Quality of Life Inventory-Cancer Module (PedsQL-3.0-Cancer) and the Parental version of the Pediatric Quality of Life Inventory-Core Module (PedsQL-4.0-Core).
Change in parents' fatigue
时间窗: T0 (before the intervention), T1 (right after the intervention : 6 months later)
Measured with the Multidimensional Fatigue Inventory (MFI-20).
Change in children's quality of life
时间窗: T0 (before the intervention), T1 (right after the intervention : 6 months later)
Self-assessment of children's quality of life. Measured with the Pediatric Quality of Life Inventory-Cancer Module (PedsQL-3.0-Cancer) and the Pediatric Quality of Life Inventory-Core Module (PedsQL-4.0-Core). Children with cancer answer to both questionnaires but their siblings only answer the PedsQL-4.0-Core.
Change in children's cancer-related fatigue
时间窗: T0 (before the intervention), T1 (right after the intervention : 6 months later)
A sense of tiredness or exhaustion linked with cancer and its treatments, that is not alleviated by sleep. Measured with the Pediatric Functional Assessment of Chronic Illness Therapy-Fatigue (pedsFACIT-F) among children with cancer and their siblings .
次要结局
- Change in the family impact of the cancer(T0 (before the intervention), T1 (right after the intervention : 6 months later))
- Change in parents' coping strategies(T0 (before the intervention), T1 (right after the intervention : 6 months later))
- Change in parents' emotional distress(T0 (before the intervention), T1 (right after the intervention : 6 months later))
研究者
Isabelle Bragard
Lecturer
University of Liege