Mind-body therapies to help anxiety in young cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter study explores whether incorporating mind-body therapies like hypnosis or relaxation alongside standard psychological care can help reduce anxiety symptoms in pediatric and young adult cancer survivors. Participants are split into age-based cohorts and choose either hypnosis or relaxation, with ten MBT sessions and nine standard care sessions over a defined period. The trial enrolled individuals who are in remission, completed intensive treatment at least three months prior, and meet anxiety criteria. Outcomes focus on changes in anxiety, with secondary observations on mood and overall well-being. It is conducted at three French centers with parental and participant consent required.

Why it matters

Who can join: the full rules

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's running

• CENTRE HOSPITALIER UNIVERSITAIRE - site NORD
  Saint-Etienne, France Recruiting
• Centre Hospitalier Universitaire Caen Normandie
  Caen, France Not yet recruiting
• Centre Hospitalier Universitaire Grenoble Alpes
  Grenoble, France Not yet recruiting
• Institut d'Hématologie et d'Oncologie Pédiatrique
  Lyon, France Not yet recruiting
• Centre Hospitalier Universitaire
  Rouen, France Not yet recruiting

Study contacts

• Principal investigator: Claire Berger, Md — Chu de Saint-Etienne
• Study coordinator: Claire BERGER, MD
• Email: claire.berger@chu-st-etienne.fr
• Phone: 04.77.12.79.37

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.