A Hypnosis-based Group Intervention to Improve Quality of Life in Children With Cancer and Their Parents.

NCT03435042 — Not applicable, Recruiting, 30 participants, University of Liege

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Registry	NCT03435042
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, supportive care
Enrollment	30 (Estimated)
Sponsor	University of Liege (Other)
Conditions	Pediatric Cancer
Interventions	Self care + Hypnosis group (Behavioral)
Dates	start 2018-01-25, primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2018-02-15, last updated 2023-07-03
Locations	1 site in Belgium

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Children with cancer + their siblings	Experimental	Behavioral: Self care + Hypnosis group
Parents of children with cancer	Experimental	Behavioral: Self care + Hypnosis group

Self care + Hypnosis group (Behavioral): Our groupal intervention is divided into 6 monthly 2-hour sessions in which some self-hypnosis exercises are proposed to participants. Self-care techniques are also discussed (knowing our own needs, self-respect, assertiveness, coping with ruminations...) and homework assignments are proposed to participants, in order to foster positive change.

+Outcome measures

Primary outcomes

Change in children's quality of life [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 parents' conception of their child's quality of life [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 children's cancer-related fatigue [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 .
Change in parents' fatigue [T0 (before the intervention), T1 (right after the intervention : 6 months later)]: Measured with the Multidimensional Fatigue Inventory (MFI-20).

Secondary outcomes

Change in the family impact of the cancer [T0 (before the intervention), T1 (right after the intervention : 6 months later)]: Impact of the child's health on the parents' quality of life and on the familily fonctioning. Measured with the Pediatric Quality of Life Inventory-Family Impact Module (PedsQL-2.0-Family Impact Module)
Change in parents' emotional distress [T0 (before the intervention), T1 (right after the intervention : 6 months later)]: Anxiety and depression of the parents measured with the Hospital Anxiety and Depression Scale (HADS)
Change in parents' coping strategies [T0 (before the intervention), T1 (right after the intervention : 6 months later)]: The way parents cope adverses events. Measured with Ways of Coping Checklist (WWC-R)

+Eligibility

Sex: All, ages: 8 Years to any, accepts healthy volunteers

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:

* /

+Locations (1)

Facility	City	Country	Status
University Hospital of Liege	Liège	Belgium	Recruiting

+Publications

Results publication: 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. PMID 30939086

+Investigators

Marie-Elisabeth Faymonville, Study director, Centre Hospitalier Universitaire de Liege