Glial Tumor
Conditions
Keywords
Sophrology, Speech therapy
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.
Interventions
BEHAVIORALSophrology
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
BEHAVIORALSpeech 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.
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Main Objective is to Compare the Level of Anxiety in the Experimental Arm With the Control Arm at 6 Months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Secondary Objective is to Evaluate the Impact of the Practice of Sophrology on the Patient's Quality of Life | 6 months | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCELINE THOMAS
Institut de Cancérologie de l'Ouest
Participant flow
Pre-assignment details
One patient in each arm did not start study assessments because individual study discontinuation criteria were met
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70 years |
| Performance Status 0 | 1 participants |
| Performance Status 1 | 3 participants |
| Performance Status 2 | 1 participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
| Speech therapy started | 6 participants |
| Surgical strategy biopsy | 3 participants |
| Surgical strategy tumorectomy | 5 participants |
| Tumor grade Grade 3 | 1 participants |
| Tumor grade Grade 4 | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 5 | 1 / 6 |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
None listed