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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03435042
Enrollment
30
Registered
2018-02-15
Start date
2018-01-25
Completion date
2028-12-31
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer

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.

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.

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes

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

* /

Design outcomes

Primary

MeasureTime frameDescription
Change in children's quality of lifeT0 (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.
Change in parents' conception of their child's quality of lifeT0 (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).
Change in children's cancer-related fatigueT0 (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 .
Change in parents' fatigueT0 (before the intervention), T1 (right after the intervention : 6 months later)Measured with the Multidimensional Fatigue Inventory (MFI-20).

Secondary

MeasureTime frameDescription
Change in parents' emotional distressT0 (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)
Change in parents' coping strategiesT0 (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)
Change in the family impact of the cancerT0 (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)

Countries

Belgium

Contacts

Primary ContactCharlotte Grégoire
ch.gregoire@uliege.be043662398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026