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Recruiting NCT03435042

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

No phase Interventional Pediatric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self care + Hypnosis group.
Who it may be relevant to
Registry conditions: Pediatric Cancer. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral Self care + Hypnosis group
    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.

Primary outcome measures

  • Change in children's quality of life [Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in parents' conception of their child's quality of life [Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in children's cancer-related fatigue [Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in parents' fatigue [Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
Secondary outcome measures (3)
  • Change in the family impact of the cancer [Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in parents' emotional distress [Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in parents' coping strategies [Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)]

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

  • /

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Belgium · 1 center
  • University Hospital of Liege — Liège

Publications

  • 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

Identifiers

NCT: NCT03435042 · Hypnose enfant cancer

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗