Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy (SOPHNEURO)

Institut Cancerologie de l'Ouest

Status: Terminated

Conditions: Glial Tumor

Treatments: Behavioral: Sophrology; Behavioral: Speech therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05189366

ICO-2020-12

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Experimental arm : Speech therapy + Sophrology

Experimental group

Description:

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.

Treatment:

Behavioral: Speech therapy

Behavioral: Sophrology

Control arm : Speech therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Speech therapy