Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy

Glial Tumor Clinical Trial

— SOPHNEURO  

Official title:

Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05189366
• Other study ID #: ICO-2020-12
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: April 2025

Study information

• Verified date: July 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: CELINE THOMAS
• Phone: +33 240679900
• Email: celine.thomas[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Communication Disorders
• Glial Tumor
• Glioma

Intervention

Behavioral:
• Sophrology
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
• Speech therapy
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.

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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