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

January 23, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

558

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
        • Centre Hospitalier Universitaire
        • Contact:
      • Caen, France, 14033
        • Centre Hospitalier Universitaire Caen Normandie
        • Contact:
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire Grenoble Alpes
        • Contact:
      • Lyon, France, 69008
      • Rouen, France, 76038
      • Saint-Etienne, France, 42055
      • Strasbourg, France, 67200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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:

HARMONY-Kids

  • Patients suffering from severe depression (CDI score > 40),
  • Patients with suicidal thoughts regardless of their CDI score,
  • Patients experiencing a cancer relapse,
  • Refusal to participate,
  • Pregnant women, women in labor, breastfeeding mothers,
  • Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than research,
  • Persons subject to legal protection measures (guardianship-curatorship) or unable to express their consent HARMONY-AYA
  • Patients suffering from severe depression (HADS-Depression score > 19)
  • Patients with suicidal thoughts regardless of their HADS-Depression score,
  • Patients with cancer relapse,
  • Refusal to participate,
  • Pregnant women, women in labor, breastfeeding mothers
  • Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than research
  • Adults subject to legal protection measures (guardianship-curatorship) or unable to give consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Behavioral: 9 sessions of standard psychological care
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
Behavioral: 9 sessions of standard psychological care
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).
Behavioral: 10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Established according to the reference scale SCARED-51 (screen for child anxiety related disorders). On this scale, each item is rated from 0 (rarely) to 2 (often), assessing the intensity of the symptom over the previous 3 months. The total score, ranging from 0 to 102 for the SCARED-R-51, is calculated by adding up the scores for all items. The higher the score, the more severe the anxiety symptoms.
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.
Time Frame: 6 months after the first conventional psychotherapy session
Established according to the Hospital Anxiety and Depression Scale (HADS). This scale comprises 14 items: 7 items relate to anxiety and 7 others to depression, allowing two separate scores to be obtained. Each response is rated from 0 to 3 on a scale that semi-quantitatively assesses the intensity of the symptom over the past week. The score for each part (anxiety/depression) is calculated by adding the values of the responses to the 7 corresponding items. Threshold scores for the two HAD subscales have been determined with the following values: 7 or less: no case, 8 to 10: doubtful case, and 11 and above: definite case.
6 months after the first conventional psychotherapy session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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: 12 months after the first conventional psychotherapy session
Established according to the reference scale SCARED-51 (screen for child anxiety related disorders). On this scale, each item is rated from 0 (rarely) to 2 (often), assessing the intensity of the symptom over the previous 3 months. The total score, ranging from 0 to 102 for the SCARED-R-51, is calculated by adding up the scores for all items. The higher the score, the more severe the anxiety symptoms.
12 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.
Time Frame: 12 months after the first conventional psychotherapy session
Established according to the Hospital Anxiety and Depression Scale (HADS). This scale comprises 14 items: 7 items relate to anxiety and 7 others to depression, allowing two separate scores to be obtained. Each response is rated from 0 to 3 on a scale that semi-quantitatively assesses the intensity of the symptom over the past week. The score for each part (anxiety/depression) is calculated by adding the values of the responses to the 7 corresponding items. Threshold scores for the two HAD subscales have been determined with the following values: 7 or less: no case, 8 to 10: doubtful case, and 11 and above: definite case.
12 months after the first conventional psychotherapy session
Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on the level of depression in subjects aged 7 to 14 years in remission from cancer or pediatric leukemia, compared to conventional psychological care alone
Time Frame: 6 months then 12 months after the first conventional psychotherapy session
Established according to the reference scale CDI (child anxiety related disorders). The CDI scale comprises 27 items, each of which is scored from 0 (absent or normal behavior for age) to 2 (severe), assessing the intensity of the symptom during the previous two weeks. The total score, ranging from 0 to 54, is calculated by adding up the scores for all items. The higher the score, the more pronounced the depressive symptoms.
6 months then 12 months after the first conventional psychotherapy session
Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on the level of depression in subjects aged 15 to 25 years in remission from cancer or pediatric leukemia, compared to conventional psychological care alone
Time Frame: 6 months then 12 months after the first conventional psychotherapy session
Established according to the Hospital Anxiety and Depression Scale (HADS). This scale comprises 14 items: 7 items relate to anxiety and 7 others to depression, allowing two separate scores to be obtained. Each response is rated from 0 to 3 on a scale that semi-quantitatively assesses the intensity of the symptom over the past week. The score for each part (anxiety/depression) is calculated by adding the values of the responses to the 7 corresponding items. Threshold scores for the two HAD subscales have been determined with the following values: 7 or less: no case, 8 to 10: doubtful case, and 11 and above: definite case.
6 months then 12 months after the first conventional psychotherapy session
Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on the quality of life of subjects aged 7 to 25 in remission from pediatric cancer or leukemia, compared to conventional psychological care alone.
Time Frame: 6 months then 12 months after the first conventional psychotherapy session
Established according to the Pediatric Quality of Life Inventory (PesQL). The Peds-QL measures the quality of life associated with the health status of children/adolescents in four areas: physical (8 questions), emotional (5 questions), social (5 questions), and academic (5 questions). For each question, there are 5 possible answers rated from 0 to 4 (0=never to 4=almost always) on a 5-point Likert scale or, in the version for children aged 5 to 7, 3 possible answers (0=never, 2=sometimes, and 4=almost always) on a 3-point Likert scale using smiley faces. The closer the total score, calculated as the average of all 23 questions, is to 100, the better the child/adolescent's quality of life.
6 months then 12 months after the first conventional psychotherapy session
Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on the coping strategies of subjects aged 7 to 17 in remission from pediatric cancer or leukemia, compared to conventional psychological care alone.
Time Frame: 6 months then 12 months after the first conventional psychotherapy session
Established according to the reference scale KidCOPE (Coping Orientation to Problems Experienced). It is a self-administered questionnaire that has been developed in two versions, one consisting of 15 items for children aged 7 to 12, and the other consisting of 10 items for adolescents aged 13 to 18. In both cases, two dimensions are measured: frequency and effectiveness. Frequency is measured on a 4-point Likert scale. Effectiveness is measured using a 4-point Likert scale for the version for younger children (7-12 years old) and a 5-point scale for the version for older children (13-18 years old), ranging from "not helpful" to "very helpful." The results consist of a percentage of the number of subjects using each of the different coping strategies.
6 months then 12 months after the first conventional psychotherapy session
Evaluate the benefits of mind-body therapy as a complement to conventional psychological care on the coping strategies of subjects aged 18 to 25 in remission from pediatric cancer or leukemia, compared to conventional psychological care alone.
Time Frame: 6 months then 12 months after the first conventional psychotherapy session
Established according to the reference scale BriefCOPE (Coping Orientation to Problems Experienced). This is a self-administered questionnaire consisting of 28 items, comprising 14 scales. The 14 scales of the inventory all contain two items rated from 1 to 4 (1=not at all, 2=occasionally, 3=often, and 4=always), and the score for each scale is always between 2 and 8. The results are presented as the average score for each scale of the inventory for all subjects; there is no overall score.
6 months then 12 months after the first conventional psychotherapy session
Determine the proportion of refusals to follow a course of treatment that includes psychological care.
Time Frame: through study completion, an average of 1 year
The proportion of subjects aged 7 to 25 who refuse a course of treatment including psychological care will be determined by the number of refusals to participate in the study.
through study completion, an average of 1 year
Determine the proportion of non-adherence to a care pathway that includes psychological support.
Time Frame: through study completion, an average of 1 year
Non-adherence to the psychological care program proposed in this study will be determined by the termination of sessions, at the initiative of the patient or the psychologist, before reaching the minimum number of sessions required, i.e., 5 psychotherapy sessions in group 1 (arm "Usual psychological care") or 5 psychotherapy sessions combined with 5 mind-body therapy sessions in group 2 ("Usual psychological care + mind-body therapy" arm).
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: CLAIRE BERGER, MD, Chu de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23CH130
  • ANSM (Other Identifier: 2025-A02220-49)
  • 2022-060 (Other Grant/Funding Number: INCA (French National Institute of Cancer))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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