Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435042
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Isabelle Bragard, University of Liege

Brief 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.


Condition or disease Intervention/treatment Phase
Pediatric Cancer Behavioral: Self care + Hypnosis group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Hypnosis-based Group Intervention to Improve Quality of Life in Children With Cancer and Their Parents.
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  • /

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435042


Contacts
Layout table for location contacts
Contact: Charlotte Grégoire 043662398 ext +32 ch.gregoire@uliege.be

Locations
Layout table for location information
Belgium
University Hospital of Liege Recruiting
Liege, Belgium, B-4000
Contact: Isabelle Bragard, Ph.D.    0032475825784    isabelle.bragard@ulg.ac.be   
Sponsors and Collaborators
University of Liege
Investigators
Layout table for investigator information
Study Director: Marie-Elisabeth Faymonville Centre Hospitalier Universitaire de Liège
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Isabelle Bragard, Lecturer, University of Liege
ClinicalTrials.gov Identifier: NCT03435042    
Other Study ID Numbers: Hypnose enfant cancer
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No