NCT03435042

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Jan 2018Dec 2028

Study Start

First participant enrolled

January 25, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

10.9 years

First QC Date

February 7, 2018

Last Update Submit

June 29, 2023

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (4)

  • 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.

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

  • 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).

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

  • 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 .

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

  • Change in parents' fatigue

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

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

Secondary Outcomes (3)

  • Change in the family impact of the cancer

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

  • Change in parents' emotional distress

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

  • Change in parents' coping strategies

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

Study Arms (2)

Children with cancer + their siblings

EXPERIMENTAL
Behavioral: Self care + Hypnosis group

Parents of children with cancer

EXPERIMENTAL
Behavioral: Self care + Hypnosis group

Interventions

Self care + Hypnosis groupBEHAVIORAL

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.

Children with cancer + their siblingsParents of children with cancer

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liege

Liège, B-4000, Belgium

RECRUITING

Related Publications (1)

  • 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: 30939086DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Self Care

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marie-Elisabeth Faymonville

    Centre Hospitalier Universitaire de Liege

    STUDY DIRECTOR

Central Study Contacts

Charlotte Grégoire

CONTACT

043662398ch.gregoire@uliege.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 15, 2018

Study Start

January 25, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)