Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy

NCT05189366 | Terminated Results

• 1 other identifier: ICO-2020-12
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Glial Tumor

Keywords

Sophrology; Speech therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Secondary Objective is to Evaluate the Impact of the Practice of Sophrology on the Patient's Quality of Life

  6 months

Study Arms (2)

Experimental arm : Speech therapy + Sophrology

EXPERIMENTAL

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; Behavioral: Speech therapy

Control arm : Speech therapy

ACTIVE COMPARATOR

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

Interventions

Sophrology BEHAVIORAL

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

Experimental arm : Speech therapy + Sophrology

Speech therapy BEHAVIORAL

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.

Control arm : Speech therapy; Experimental arm : Speech therapy + Sophrology

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Glioma; Communication Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Limitations and Caveats

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

Results Point of Contact

• Title: Céline Thomas
• Organization: Institut de Cancérologie de l'Ouest

celine.thomas@ico.unicancer.fr

+33240679900

Study Officials

• CELINE THOMAS

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 12, 2022
• Study Start: October 17, 2022
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-03

Locations

FR (1)