Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy

Study Overview
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Brief Summary
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Patients with brain tumours experience a loss of independence, which may occur suddenly or gradually. Communication with the patient may be rapidly impaired, due to impaired alertness, language and/or neurocognitive disorders. In addition to these clinical symptoms, there is a high level of anxiety and depression in this population due to the severity of the diagnosis, with a major impact on the patients' quality of life. In this study, we are mainly interested in the proportion of this population with communication disorders where speech therapy is important In order to better take into account anxiety, which is often difficult to verbalise due to communication problems, sophrology can be proposed as an alternative to psychological support, which is often too complicated or inappropriate. After having noted positive feedback from patients after joint speech therapy and sophrology treatment, we wish to evaluate the interest of coupling sophrology treatment for patients with glial tumours requiring speech therapy. Our hypothesis is that this association would improve the level of anxiety, the quality of life and have a positive impact on the patient's speech therapy.

Official Title
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Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy

Conditions
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Glial Tumor

Intervention / Treatment
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* Behavioral: Sophrology
* Behavioral: Speech therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically proven grade III and IV glial tumours requiring speech therapy; Patient willing to start outpatient speech therapy; Patient aged 18 years and over; Informed patient who has signed consent; Patient affiliated to a social security scheme. Exclusion Criteria: Patient who has already had an initiation to sophrology in the context of his pathology; PS ≥ 4 ; Patients suffering from psychiatric disorders; delusional phases, schizophrenia against the practice of sophrology; Patient unable to follow the protocol (filling in questionnaires, attendance of sophrology and/or speech therapy sessions) for geographical, social or psychological reasons; Patients who do not speak French; Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian. Women who are pregnant, likely to be pregnant or breastfeeding;
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm : Speech therapy + Sophrology<br>In the experimental arm, patients will receive 6 sessions of sophrology. The sessions are individual and last approximately 50 minutes. In addition to the sophrology sessions, patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition. | Behavioral: Sophrology<br>* Sophrology is a relaxation method that's sometimes referred to as hypnosis, psychotherapy, or a complementary therapy. Sophrology uses techniques such as: hypnosis, visualization, meditation, mindfulness, breathing exercises, gentle movements, body awareness... Sophrology techniques may be useful during medical procedures that cause stress and discomfort. Sophrology techniques may be useful during medical procedures that cause stress and discomfort. Patients will receive 6 sessions of sophrology<br>Behavioral: Speech therapy<br>* Speech therapy is a treatment that can help improve communication skills. patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.<br>|
| Active Comparator: Control arm : Speech therapy<br>Patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition. | Behavioral: Speech therapy<br>* Speech therapy is a treatment that can help improve communication skills. patients will benefit from two speech therapy sessions per week for 6 months, lasting from 30 minutes to 1 hour depending on the patient's general condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main objective is to compare the level of anxiety in the experimental arm with the control arm at 6 months. | Anxiety levels will be measured using the Hospital Anxiety and Depression Scale at 6 months in both treatment arms. The quality of life scale consists of 14 items scored from 0 to 3. A score of 0 indicates that the patient has no anxiety disorder, a score of 21 indicates that the patient has a severe anxiety disorder. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective is to evaluate the impact of the practice of sophrology on the patient's quality of life | Quality of life will be assessed by quality of life questionnaires at baseline and after 3 and 6 months of treatment. These are the QLQ-C30 v3 questionnaire and the brain-specific module EORTC-BN20 ; | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sophrology, Speech therapy