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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-25
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

558 Participants
are divided into 2 treatment groups
Group A: Standard psychological careActive comparator 1 intervention
Group B: Standard psychological care + mind-body therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months after the first conventional psychotherapy session
2

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.

Time frame
6 months after the first conventional psychotherapy session

Secondary outcomes

1

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.

Time frame
12 months after the first conventional psychotherapy session
2

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.

Time frame
12 months after the first conventional psychotherapy session
3

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.

Time frame
6 months then 12 months after the first conventional psychotherapy session
4

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.

Time frame
6 months then 12 months after the first conventional psychotherapy session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.