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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Study ID
NCT07380672
Status
Not Yet Recruiting

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Conditions

  • Adolescent Cancer Survivors
  • Anxiety
  • Childhood Cancer Survivors

Eligibility Criteria

Sex
ALL
Age
7 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 2, 2026
Start date
Sep 2, 2026
Status verified
Jan 2026
Primary completion
Jan 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
558 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Standard psychological care
    Conventional follow-up. 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).
  • Experimental: Standard psychological care + mind-body therapy
    Standard psychological care (conventional follow-up) + psychocorporal therapy over the same period, with the patient choosing between relaxation and hypnosis

Primary Outcome Measure

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. [ Time Frame: 6 months after the first conventional psychotherapy session ]

Central Contacts

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