Clinical trial NCT05189366: Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
Official title: Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glial Tumor
Keywords: Sophrology
Speech therapy
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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;

Primary outcomes:
measure: The main objective is to compare the level of anxiety in the experimental arm with the control arm at 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: The secondary objective is to evaluate the impact of the practice of sophrology on the patient's quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: CELINE THOMAS
role: PRINCIPAL_INVESTIGATOR
References: