IMpact of Mind-body Therapies (HYpnosis and Relaxation) on Anxiety in Children, Adolescents and Young Adults Who Had Been Treated in ONcology. Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 558
- 试验地点
- 12
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: 9 sessions of standard psychological care (Behavioral)
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).
干预措施: 9 sessions of standard psychological care (Behavioral)
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
干预措施: 10 mind-body therapy sessions (hypnosis or relaxation, depending on the patient's choice) (Behavioral)
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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.
次要结局
- 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(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 anxiety level in subjects aged 7 to 14 years old in remission from cancer or pediatric leukemia, compared to conventional psychological care alone.(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.(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(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.(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.(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.(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.(through study completion, an average of 1 year)
- Determine the proportion of non-adherence to a care pathway that includes psychological support.(through study completion, an average of 1 year)