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

Centre Hospitalier Universitaire de Saint Etienne

Status: Begins enrollment this month

Conditions: Adolescent Cancer Survivors; Childhood Cancer Survivors; Anxiety

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07380672

ANSM (Other Identifier)

2022-060 (Other Grant/Funding Number)

23CH130

Details and patient eligibility

About

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.

Enrollment: 558 estimated patients

Sex: All

Ages: 7 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

HARMONY KIDS

• Patients aged at least 7 and under 15 at the time of inclusion, diagnosed with pediatric cancer,
• Patients considered to be in complete remission from pediatric cancer, whose intensive treatment ended at least 3 months prior to inclusion
• 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 aged at least 15 and no more than 25 years old at the time of inclusion, diagnosed with pediatric cancer before the age of 18,
• Patients considered to be in complete remission from pediatric cancer, whose intensive treatment ended at least 3 months prior to inclusion,
• 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.

Exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

Standard psychological care

Active Comparator group

Description:

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).

Treatment:

Behavioral: 9 sessions of standard psychological care

Standard psychological care + mind-body therapy

Experimental group

Description:

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

Treatment:

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

Behavioral: 9 sessions of standard psychological care