IMpact of Mind-body Therapies (HYpnosis and Relaxation) on Anxiety in Children, Adolescents and Young Adults Who Had Been Treated in ONcology. Multicenter Study.
Recruiting · NCT07380672 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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
- 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.
Where it is running
10 locations listed.
- Centre Hospitalier Universitaire Caen Normandie - Caen, France
- Centre Hospitalier Universitaire Caen Normandie - Caen, France
- Centre Hospitalier Universitaire Grenoble Alpes - Grenoble, France
- Centre Hospitalier Universitaire Grenoble Alpes - Grenoble, France
- Institut d'Hématologie et d'Oncologie Pédiatrique - Lyon, France
- Institut d'Hématologie et d'Oncologie Pédiatrique - Lyon, France
- Centre Hospitalier Universitaire - Rouen, France
- Centre Hospitalier Universitaire - Rouen, France
- CENTRE HOSPITALIER UNIVERSITAIRE - site NORD - Saint-Etienne, France
- CENTRE HOSPITALIER UNIVERSITAIRE - site NORD - Saint-Etienne, France