Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03435042

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Liege

Liège, B-4000, Belgium

Location status: Recruiting

Location contact

Isabelle Bragard, Ph.D.

CONTACT

[email protected]

0032475825784

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • /

Treatment and study plan

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.

Primary outcomes

  1. Change in children's quality of life

    Time frame: 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.

  2. 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)

    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).

  3. Change in children's cancer-related fatigue

    Time frame: 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 .

  4. Change in parents' fatigue

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

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

Secondary outcomes

  1. Change in the family impact of the cancer

    Time frame: 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)

  2. Change in parents' emotional distress

    Time frame: 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)

  3. Change in parents' coping strategies

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Grégoire

CONTACT

[email protected]

043662398 ext. +32

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Feb 15, 2018
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.