Adolescent Cancer SurvivorsHARMONY-ImpactNCT07380672
IMpact of Mind-body Therapies (HYpnosis and Relaxation) on Anxiety in Children, Adolescents and Young Adults Who Had Been Treated in ONcology. Multicenter Study.
A study testing 10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice) and 9 sessions of standard psychological care in people with Adolescent Cancer Survivors and Childhood Cancer Survivors, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 25 years
- Conditions the study is for
- Adolescent Cancer Survivors, Childhood Cancer Survivors, Anxiety
- What is being tested?
- 10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice) and 9 sessions of standard psychological care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 5 sitesFrance
- Study dates
- 4 Aug 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Caen Normandie
Caen, 14033
Marianna DEPARIS, MD, 02.31.27.27.12 ext. +33, deparis-m@chu-caen.fr
- Not yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043
Anne PAGNIER, MD, 04.76.76.72.50 ext. +33, APagnier@chu-grenoble.fr
- Not yet recruiting
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, 69008
Amandine BERTRAND, MD, 04.69.16.66.85 ext. +33, amandine.bertrand@lyon.unicancer.fr
- Not yet recruiting
Centre Hospitalier Universitaire
Rouen, 76038
Aude MARIE-CARDINE, MD, 02.32.88.81.91 ext. +33, aude.marie-cardine@chu-rouen.fr
- Recruiting
CENTRE HOSPITALIER UNIVERSITAIRE - site NORD
Saint-Etienne, 42055
Sandrine THOUVENIN-DOULET, MD, 04.77.82.88.08 ext. +33, sandrine.thouvenin@chu-st-etienne.fr
About this study
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.
- Being tested
- 10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice), 9 sessions of standard psychological care
- Keywords
- childhood cancer survivor, anxiety, depression, psychology, body mind therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice)Behavioural
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 careBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard psychological care | Active comparator | 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). Receives: Behavioral: 9 sessions of standard psychological care |
| Standard psychological care + mind-body therapy | Experimental | Standard psychological care (conventional follow-up) + psychocorporal therapy over the same period, with the patient choosing between relaxation and hypnosis Receives: Behavioral: 10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice); Behavioral: 9 sessions of standard psychological care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
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.
Measured: 6 months after the first conventional psychotherapy session
Secondary outcomes (9)
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.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: through study completion, an average of 1 year
Determine the proportion of non-adherence to a care pathway that includes psychological support.
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).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start4 Aug 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This interventional study is divided into two studies, based on patient age, entitled HARMONY-Kids for 7-14 year olds and HARMONY-AYA for 15-25 year olds. The HARMONY-Kids and HARMONY-AYA studies are multicenter, prospective, randomized, open-label clinical trials comparing two treatment strategies : * A control group consisting of patients receiving "usual psychological care" (Group 1), * An experimental group consisting of patients receiving "usual psychological care + psychocorporal therapy (hypnosis or relaxation)" (Group 2). Centralized randomization, stratified by center and by the time between diagnosis and inclusion (≤ 18 months / \> 18 months), will be performed for each of the two studies, using dedicated software. The various therapies will last six months. The respective populations of these two studies will be analyzed separately and will never be merged or compared with each other.
- Masking
- None (open label)
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CLAIRE BERGER, MD, Principal investigator, CHU DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380672
- Sponsor's protocol ID
- 23CH130
- Other IDs
- 2022-060, ANSM
- Acronym
- HARMONY-Impact
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMpact of Mind-body Therapies (HYpnosis and Relaxation) on Anxiety in Children, Adolescents and Young Adults Who Had Been Treated in ONcology. Multicenter Study.
- ClinicalTrials.gov ID
- NCT07380672
- Acronym / sponsor ID
- HARMONY-Impact / 23CH130
- Keywords
- childhood cancer survivor, anxiety, depression, psychology, body mind therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This interventional study is divided into two studies, based on patient age, entitled HARMONY-Kids for 7-14 year olds and HARMONY-AYA for 15-25 year olds. The HARMONY-Kids and HARMONY-AYA studies are multicenter, prospective, randomized, open-label clinical trials comparing two treatment strategies : * A control group consisting of patients receiving "usual psychological care" (Group 1), * An experimental group consisting of patients receiving "usual psychological care + psychocorporal therapy (hypnosis or relaxation)" (Group 2). Centralized randomization, stratified by center and by the time between diagnosis and inclusion (≤ 18 months / > 18 months), will be performed for each of the two studies, using dedicated software. The various therapies will last six months. The respective populations of these two studies will be analyzed separately and will never be merged or compared with each other.
| Arm | Type | Receives |
|---|---|---|
| Standard psychological care | Active comparator | Behavioral: 9 sessions of standard psychological careConventional 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). |
| Standard psychological care + mind-body therapy | Experimental | Behavioral: 10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice), Behavioral: 9 sessions of standard psychological careStandard psychological care (conventional follow-up) + psychocorporal therapy over the same period, with the patient choosing between relaxation and hypnosis |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Standard psychological care + mind-body therapy |
| 9 sessions of standard psychological care9 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). | Behavioural | Standard psychological care, Standard psychological care + mind-body therapy |
Primary outcome
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.
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
Determine the proportion of non-adherence to a care pathway that includes psychological support.
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CLAIRE BERGER, MD principal investigator
CHU DE SAINT-ETIENNE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice) and 9 sessions of standard psychological care in people with Adolescent Cancer Survivors and Childhood Cancer Survivors, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire BERGER, MD (04.77.12.79.37 ext. +33, claire.berger@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.