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RecruitingNCT03435042Updated Jul 3, 2023

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

An interventional study of Self care + Hypnosis group in Pediatric Cancer, sponsored by University of Liege. Recruiting at 1 site in Belgium. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by University of Liege · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
8 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pediatric Cancer

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03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Liege is the lead sponsor of 250 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • /
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Children with cancer + their siblings

    Behavioral: Self care + Hypnosis group

  • Experimental
    Parents of children with cancer

    Behavioral: Self care + Hypnosis group

Interventions

  • BehavioralSelf 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.

06

What researchers measure

Primary outcomes

  1. Change in children's quality of life

    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.

    Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)

  2. Change in parents' conception of their child's quality of life

    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).

    Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)

  3. Change in children's cancer-related fatigue

    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 .

    Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)

  4. Change in parents' fatigue

    Measured with the Multidimensional Fatigue Inventory (MFI-20).

    Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)

Secondary outcomes

  1. Change in the family impact of the cancer

    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)

    Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)

  2. Change in parents' emotional distress

    Anxiety and depression of the parents measured with the Hospital Anxiety and Depression Scale (HADS)

    Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)

  3. Change in parents' coping strategies

    The way parents cope adverses events. Measured with Ways of Coping Checklist (WWC-R)

    Time frame: T0 (before the intervention), T1 (right after the intervention : 6 months later)

07

Study locations

1 of 1 sites recruiting
  • University Hospital of Liege
    Liège, B-4000, Belgium
    Recruiting
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References and documents

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. PubMed 30939086 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03435042
Responsible party
Isabelle Bragard (Lecturer, University of Liege) — Principal investigator
First posted
Feb 15, 2018
Start date
Jan 25, 2018
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jul 3, 2023

Study contacts

Charlotte Grégoire
Contact
ch.gregoire@uliege.be
043662398 ext. +32
Marie-Elisabeth Faymonville
study director · Centre Hospitalier Universitaire de Liege

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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