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

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.

Study Overview

• Status: Terminated
• Conditions: Glial Tumor
• Intervention / Treatment: Behavioral: Sophrology; Behavioral: Speech therapy

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm : Speech therapy + Sophrology; 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; 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; Behavioral: 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.
Active Comparator: Control arm : Speech therapy; 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; 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.

What is the study measuring?

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 was measured with the EORTC Quality of Life Questionnaire - Core 30 (QLQ C30) and Brain Neoplasm Module (QLQ BN20) Both use 0-100 transformed scores. For QLQ C30: higher functional and global health scores = better outcome; higher symptom scores = worse symptoms. For QLQ BN20: all subscale scores (future uncertainty, visual disorder, motor dysfunction, communication deficit, plus single symptom items) range 0-100, with higher scores indicating worse symptoms. No total score is calculated for BN20.	6 months

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: CELINE THOMAS, Institut de Cancérologie de l'Ouest

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): November 5, 2024
• Study Completion (Actual): November 5, 2024

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Speech therapy; Sophrology
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neoplasms; Neoplasms by Histologic Type; Neurobehavioral Manifestations; Neoplasms, Glandular and Epithelial; Neurodevelopmental Disorders; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Glioma; Communication Disorders; Therapeutics; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Speech Therapy
• Other Study ID Numbers: ICO-2020-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No