Clinical trial NCT03435042: A Hypnosis-based Group Intervention to Improve Quality of Life in Children With Cancer and Their Parents.
Official title: A Hypnosis-based Group Intervention to Improve Quality of Life in Children With Cancer and Their Parents.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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
* Parents:

  * To have a child who suffer from cancer
  * To speak french

Exclusion Criteria:

* /

Primary outcomes:
measure: Change in children's quality of life
timeFrame: T0 (before the intervention), T1 (right after the intervention : 6 months later)
measure: Change in parents' conception of their child's quality of life
timeFrame: T0 (before the intervention), T1 (right after the intervention : 6 months later)
measure: Change in children's cancer-related fatigue
timeFrame: T0 (before the intervention), T1 (right after the intervention : 6 months later)
measure: Change in parents' fatigue
timeFrame: T0 (before the intervention), T1 (right after the intervention : 6 months later)
Secondary outcomes:
measure: Change in the family impact of the cancer
timeFrame: T0 (before the intervention), T1 (right after the intervention : 6 months later)
measure: Change in parents' emotional distress
timeFrame: T0 (before the intervention), T1 (right after the intervention : 6 months later)
measure: Change in parents' coping strategies
timeFrame: T0 (before the intervention), T1 (right after the intervention : 6 months later)
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University Hospital of Liege
Study officials:
affiliation: Centre Hospitalier Universitaire de Liege
name: Marie-Elisabeth Faymonville
role: STUDY_DIRECTOR
References:
citation: Gregoire C, Chantrain C, Faymonville ME, Marini J, Bragard I. A HYPNOSIS-BASED GROUP INTERVENTION TO IMPROVE QUALITY OF LIFE IN CHILDREN WITH CANCER AND THEIR PARENTS. Int J Clin Exp Hypn. 2019 Apr-Jun;67(2):117-135. doi: 10.1080/00207144.2019.1580965.