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

N/ANot Yet RecruitingNCT07380672

Centre Hospitalier Universitaire de Saint Etienne558 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

558

Conditions

Adolescent Cancer Survivors Childhood Cancer Survivors

Eligibility

Sex: ALLMin age: 7 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months after the first conventional psychotherapy session

Secondary Outcomes

Time frame: 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

Established according to the reference scale CDI (child anxiety related disorders). The CDI scale comprises 27 items, each of which is scored from 0 (absent or normal behavior for age) to 2 (severe), assessing the intensity of the symptom during the previous two weeks. The total score, ranging from 0 to 54, is calculated by adding up the scores for all items. The higher the score, the more pronounced the depressive symptoms.