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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: 6 months after the first conventional psychotherapy session]

Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 coping strategies of subjects aged 7 to 17 in remission from pediatric cancer or leukemia, compared to conventional psychological care alone. [Срок оценки: 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 coping strategies of subjects aged 18 to 25 in remission from pediatric cancer or leukemia, compared to conventional psychological care alone. [Срок оценки: 6 months then 12 months after the first conventional psychotherapy session]
• Determine the proportion of refusals to follow a course of treatment that includes psychological care. [Срок оценки: through study completion, an average of 1 year]
• Determine the proportion of non-adherence to a care pathway that includes psychological support. [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

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.

Критерии исключения

For HARMONY-Kids:

• Presence of active suicidal ideation and/or need for urgent psychiatric care,
• Patient experiencing a cancer relapse,
• Refusal to participate,
• Pregnant women, women in labor, or breastfeeding mothers,
• Individuals deprived of their liberty, hospitalized without consent, or hospitalized for purposes other than research,
• Individuals subject to legal guardianship or conservatorship, or those unable to give informed consent

For HARMONY-AYA:

• Presence of active suicidal ideation and/or need for urgent psychiatric care,
• Patients experiencing a cancer relapse,
• Refusal to participate,
• Pregnant women, women in labor, or breastfeeding mothers,
• Individuals deprived of their liberty, hospitalized without consent, or hospitalized for purposes other than research,
• Adults subject to legal guardianship or conservatorship, or unable to give informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 5 центров

• Centre Hospitalier Universitaire Caen Normandie — Caen
• Centre Hospitalier Universitaire Grenoble Alpes — Grenoble
• Institut d'Hématologie et d'Oncologie Pédiatrique — Lyon
• Centre Hospitalier Universitaire — Rouen
• CENTRE HOSPITALIER UNIVERSITAIRE - site NORD — Saint-Etienne

Идентификаторы

NCT: NCT07380672 · 23CH130 · 2022-060 · ANSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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