IMpact of Mind-body Therapies (HYpnosis and Relaxation) on Anxiety in Children, Adolescents and Young Adults Who Had Been Treated in ONcology. Multicenter Study.

NCT07380672 | Not Yet Recruiting

• 3 other identifiers: 23CH1302022-060ANSM
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 7

Brief Summary

In France today, it is estimated that one in 850 people aged between 20 and 45 has been cured of cancer in childhood. Some descriptive studies have established that cancer diagnosis and treatment can affect psychological health, with an increased risk of depression, post-traumatic stress, anxiety and suicidal risk. A French study published by our team in 2015 and 2020 also showed that, as adults, 40% of former pediatric cancer patients experienced symptoms of anxiety, a rate significantly higher than that of the general French population (25%). While it is well established that it is essential to detect the onset of anxiety-depressive disorders and, if necessary, to set up conventional psychological treatment (CPT), few studies have sought to show the benefit of complementing this conventional CPT with mind-body therapies (MBT) in the post-cancer pediatric setting. This project aims to determine the benefit of mind-body therapies (hypnosis and relaxation) as a complement to conventional psychological treatment (CPT) in the management of anxiety in children, adolescents and young adults in remission from pediatric cancer or leukemia.

Conditions

Childhood Cancer Survivors; Adolescent Cancer Survivors; Anxiety

Keywords

childhood cancer survivor; anxiety; depression; psychology; body mind therapy

Outcome Measures

Primary Outcomes (2)

• Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on anxiety level in subjects aged 7 to 14 years old in remission from cancer or pediatric leukemia, compared to conventional psychological care alone.

  Established according to the reference scale SCARED-51 (screen for child anxiety related disorders). On this scale, each item is rated from 0 (rarely) to 2 (often), assessing the intensity of the symptom over the previous 3 months. The total score, ranging from 0 to 102 for the SCARED-R-51, is calculated by adding up the scores for all items. The higher the score, the more severe the anxiety symptoms.

  6 months after the first conventional psychotherapy session

• Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on anxiety level in subjects aged 15 to 25 years old in remission from cancer or pediatric leukemia, compared to conventional psychological care alone.

  Established according to the Hospital Anxiety and Depression Scale (HADS). This scale comprises 14 items: 7 items relate to anxiety and 7 others to depression, allowing two separate scores to be obtained. Each response is rated from 0 to 3 on a scale that semi-quantitatively assesses the intensity of the symptom over the past week. The score for each part (anxiety/depression) is calculated by adding the values of the responses to the 7 corresponding items. Threshold scores for the two HAD subscales have been determined with the following values: 7 or less: no case, 8 to 10: doubtful case, and 11 and above: definite case.

  6 months after the first conventional psychotherapy session

Secondary Outcomes (9)

• Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on anxiety level in subjects aged 7 to 14 years old in remission from cancer or pediatric leukemia, compared to conventional psychological care alone.

  12 months after the first conventional psychotherapy session

• Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on anxiety level in subjects aged 15 to 25 years old in remission from cancer or pediatric leukemia, compared to conventional psychological care alone.

  12 months after the first conventional psychotherapy session

• Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on the level of depression in subjects aged 7 to 14 years in remission from cancer or pediatric leukemia, compared to conventional psychological care alone

  6 months then 12 months after the first conventional psychotherapy session

• Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on the level of depression in subjects aged 15 to 25 years in remission from cancer or pediatric leukemia, compared to conventional psychological care alone

  6 months then 12 months after the first conventional psychotherapy session

• Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on the quality of life of subjects aged 7 to 25 in remission from pediatric cancer or leukemia, compared to conventional psychological care alone.

  6 months then 12 months after the first conventional psychotherapy session

Study Arms (2)

Standard psychological care

ACTIVE COMPARATOR

Conventional follow-up. 9 sessions of standard psychological care to be completed within a maximum of 6 months (1 session every 2 weeks for 2 months, then 1 session per month for 4 months).

Behavioral: 9 sessions of standard psychological care

Standard psychological care + mind-body therapy

EXPERIMENTAL

Standard psychological care (conventional follow-up) + psychocorporal therapy over the same period, with the patient choosing between relaxation and hypnosis

Behavioral: 10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice); Behavioral: 9 sessions of standard psychological care

Interventions

10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice) BEHAVIORAL

10 sessions to be completed within a maximum of 6 months (1 session every 2 weeks for 4 months, then 1 session per month for 2 months). Sessions conducted alternately or on the same day as conventional psychotherapy sessions.

Standard psychological care + mind-body therapy

9 sessions of standard psychological care BEHAVIORAL

9 sessions of standard psychological care to be completed within a maximum of 6 months (1 session every 2 weeks for 2 months, then 1 session per month for 4 months).

Standard psychological care; Standard psychological care + mind-body therapy

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HARMONY KIDS
• Patients receiving follow-up care after pediatric cancer at one of the participating centers,
• Patients with anxiety disorders (SCARED-R score ≥ 31)
• Patients affiliated with or eligible for social security,
• Patients and their parents (or legal guardians) who have received informed consent about the study and co-signed, with the investigator, a consent form to participate in the study.
• HARMONY AYA
• Patients receiving follow-up care after pediatric cancer at one of the participating centers,
• Patients with anxiety disorders (HADS-Anxiety score ≥ 8)
• Patients affiliated with or eligible for social security,
• For adult patients: patients who have received informed information about the study and have co-signed, with the investigator, a consent form to participate in the study,
• For minors: patients and their parents (or legal guardians) who have received informed consent about the study and have co-signed, with the investigator, a consent form for participation in the study.

You may not qualify if:

• HARMONY-Kids
• Patients suffering from severe depression (CDI score \> 40),
• Patients with suicidal thoughts regardless of their CDI score,
• Patients experiencing a cancer relapse,
• Refusal to participate,
• Pregnant women, women in labor, breastfeeding mothers,
• Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than research,
• Persons subject to legal protection measures (guardianship-curatorship) or unable to express their consent HARMONY-AYA
• Patients suffering from severe depression (HADS-Depression score \> 19)
• Patients with suicidal thoughts regardless of their HADS-Depression score,
• Patients with cancer relapse,
• Refusal to participate,
• Pregnant women, women in labor, breastfeeding mothers
• Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than research
• Adults subject to legal protection measures (guardianship-curatorship) or unable to give consent.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (7)

Centre Hospitalier Universitaire

Angers, 49933, France

Location

Centre Hospitalier Universitaire Caen Normandie

Caen, 14033, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38043, France

Location

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, 69008, France

Location

Centre Hospitalier Universitaire

Rouen, 76038, France

Location

CENTRE HOSPITALIER UNIVERSITAIRE - site NORD

Saint-Etienne, 42055, France

Location

CENTRE HOSPITALIER UNIVERSITAIRE - site HAUTEPIERRE

Strasbourg, 67200, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• CLAIRE BERGER, MD

  CHU DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire BERGER, MD

CONTACT

04.77.12.79.37; claire.berger@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This interventional study is divided into two studies, based on patient age, entitled HARMONY-Kids for 7-14 year olds and HARMONY-AYA for 15-25 year olds. The HARMONY-Kids and HARMONY-AYA studies are multicenter, prospective, randomized, open-label clinical trials comparing two treatment strategies : * A control group consisting of patients receiving "usual psychological care" (Group 1), * An experimental group consisting of patients receiving "usual psychological care + psychocorporal therapy (hypnosis or relaxation)" (Group 2). Centralized randomization, stratified by center and by the time between diagnosis and inclusion (≤ 18 months / \> 18 months), will be performed for each of the two studies, using dedicated software. The various therapies will last six months. The respective populations of these two studies will be analyzed separately and will never be merged or compared with each other.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 2, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

FR (7)