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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03435042
• Other study ID #: Hypnose enfant cancer
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2023
• Source: University of Liege
• Contact: Charlotte Grégoire
• Phone: 043662398
• Email: ch.gregoire[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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:

• /

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital of Liege	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Change in the family impact of the cancer	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)
Secondary	Change in parents' emotional distress	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)
Secondary	Change in parents' coping strategies	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)