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

June 29, 2023 updated by: Isabelle Bragard, University of Liege

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Liege, Belgium, B-4000
        • Recruiting
        • University Hospital of Liege
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  • /

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with cancer + their siblings
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.
Experimental: Parents of children with cancer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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).
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)
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 .
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)
Measured with the Multidimensional Fatigue Inventory (MFI-20).
T0 (before the intervention), T1 (right after the intervention : 6 months later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Anxiety and depression of the parents measured with the Hospital Anxiety and Depression Scale (HADS)
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)
The way parents cope adverses events. Measured with Ways of Coping Checklist (WWC-R)
T0 (before the intervention), T1 (right after the intervention : 6 months later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Investigators

  • Study Director: Marie-Elisabeth Faymonville, Centre Hospitalier Universitaire de Liège

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Hypnose enfant cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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