NCT07380672Recruiting
IMpact of Mind-body Therapies (HYpnosis and Relaxation) on Anxiety in Children, Adolescents and Young Adults Who Had Been Treated in ONcology. Multicenter Study.
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 558 (estimated)
- First submitted
- 15 Jan 2026
- Start date
- 4 Aug 2026
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Diseases
- Childhood cancers
- NCT number
- NCT07380672
What you commit to
- Study type: Interventional
- Planned participants: 558
- From 4 Aug 2026 to the primary completion date, 1 Jan 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of active suicidal ideation and/or need for urgent psychiatric care,
- Patient experiencing a cancer relapse,
- Presence of active suicidal ideation and/or need for urgent psychiatric care,
- Patients experiencing a cancer relapse,
Other
- For HARMONY-Kids:
- 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:
- 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.
Who the study is looking for
- 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.
Age in the registry: 7 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Caen Normandie Coordinator of this site? Confirm its status | Caen | France | Not yet recruiting |
| Centre hospitalier universitaire Grenoble-Alpes Coordinator of this site? Confirm its status | Grenoble | France | Not yet recruiting |
| Institut d'Hématologie et d'Oncologie Pédiatrique Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Centre Hospitalier Universitaire Coordinator of this site? Confirm its status | Rouen | France | Not yet recruiting |
| CENTRE HOSPITALIER UNIVERSITAIRE - site NORD Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.