Using sophrology to help patients with brain tumors who need speech therapy
Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
This study is testing if combining a relaxation technique called sophrology with regular speech therapy can help patients with brain tumors who have trouble communicating and are feeling anxious or depressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Locations | 1 site (Saint-Herblain) |
| Trial ID | NCT05189366 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with glial tumors who experience communication disorders and high levels of anxiety and depression. It aims to evaluate the effectiveness of combining sophrology, a relaxation technique, with traditional speech therapy to improve patient outcomes. The study will assess the proportion of patients benefiting from this dual approach, particularly in managing anxiety that may be difficult to express verbally. Participants will be required to attend outpatient speech therapy sessions while engaging in sophrology practices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with histologically confirmed grade III or IV glial tumors who require speech therapy.
Not a fit: Patients with psychiatric disorders, those who have previously undergone sophrology for their condition, or individuals unable to follow the study protocol will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance communication abilities and reduce anxiety in patients with glial tumors, significantly improving their quality of life.
How similar studies have performed: While the combination of sophrology and speech therapy is innovative, previous studies have shown positive feedback from patients using these methods separately.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Saint-Herblain
- Institut de Cancérologie de l'Ouest — Saint-Herblain, France (Recruiting)
Study contacts
- Principal investigator: Celine Thomas — Institut de Cancérologie de l'Ouest
- Study coordinator: Celine Thomas
- Email: celine.thomas@ico.unicancer.fr
- Phone: +33 240679900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.