Recruitment difficulties

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.

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;
• Performance Status ≥ 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;

from enrollment until end of participation (up to 6 months)

A distinction is made in the protocol between Adverse Events (AEs) and Adverse Reactions (ARs).

Only Adverse Reactions were systematically collected during the study. However, Serious Adverse Events that occurred during the study period were captured through safety follow up procedures and are therefore reported in the Serious Adverse Events table, as required by ClinicalTrials.gov.

The Adverse Events section has now been revised for consistency and clarity.

Despite amendments and team efforts, recruitment was mainly hindered by the lack of available speech therapists. The frailty of the population, with rapid clinical deterioration, further limited follow-up feasibility. Consequently, the sponsor closed recruitment early. Descriptive and non-parametric analyses were performed, the small sample size precluded sufficient statistical power.Ultimately, organizational constraints and patient fragility prevented continuation under satisfactory conditions