Not Yet RecruitingNot Applicable

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

France558 participantsStarted 2026-09-02

Plain-language summary

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 participate

Age range

7 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 inve…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is specifically for children and young adults aged 7 to 25 who are already in remission from cancer or leukemia, would my child actually meet the eligibility criteria based on where they are in their treatment right now?
2This study is testing hypnosis and relaxation techniques on top of regular psychological care rather than replacing it — does that mean my child would still receive their standard psychological support throughout the trial, and do you think that combined approach makes sense for their current level of anxiety?
3The trial hasn't started recruiting yet — do you have any sense of when it might open and whether waiting for it could affect my child's anxiety treatment in the meantime, or should we be pursuing other options now?
4Since this is listed as a Phase NA study focused on measuring anxiety levels in two separate age groups, what does the current evidence say about whether mind-body therapies like hypnosis are helpful for cancer survivors with anxiety, so we can weigh how much is already known versus what this trial is still trying to find out?
5Given that this is a multicenter study, would my child need to travel to a specific site to participate, and is that kind of commitment realistic for our family situation right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 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.

Timeframe: 6 months after the first conventional psychotherapy session

Trial details

NCT IDNCT07380672

SponsorCentre Hospitalier Universitaire de Saint Etienne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

Contact for this trial

Claire BERGER, MD

04.77.12.79.37 claire.berger@chu-st-etienne.fr

View on ClinicalTrials.gov More Adolescent Cancer Survivors trials

Plain-language summary

Who can participate

Age range

7 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: 6 months after the first conventional psychotherapy session