Glial TumorSOPHNEURONCT05189366
Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
A study testing Sophrology and Speech therapy in people with Glial Tumor, run by Institut Cancerologie de l'Ouest at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glial Tumor
- What is being tested?
- Sophrology and Speech therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2022to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Sophrology, Speech therapy
- Keywords
- Sophrology, Speech therapy
- Medical subject headings
- Glioma, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SophrologyBehavioural
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start17 Oct 2022
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glial TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CELINE THOMAS, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189366
- Sponsor's protocol ID
- ICO-2020-12
- Acronym
- SOPHNEURO
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2021
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
- ClinicalTrials.gov ID
- NCT05189366
- Acronym / sponsor ID
- SOPHNEURO / ICO-2020-12
- Conditions
- Glial Tumor
- Keywords
- Sophrology, Speech therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Posted 14 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm : Speech therapy + Sophrology | Experimental | Behavioral: Sophrology, Behavioral: Speech therapyIn 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. |
| Control arm : Speech therapy | Active comparator | Behavioral: Speech therapyPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SophrologySophrology 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 | Behavioural | Experimental arm : Speech therapy + Sophrology |
| Speech therapySpeech 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. | Behavioural | Control arm : Speech therapy, Experimental arm : Speech therapy + Sophrology |
Primary outcome
The Main Objective is to Compare the Level of Anxiety in the Experimental Arm With the Control Arm at 6 Months.
Time frame: 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.
1 secondary outcome
The Secondary Objective is to Evaluate the Impact of the Practice of Sophrology on the Patient's Quality of Life
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CELINE THOMAS principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sophrology and Speech therapy in people with Glial Tumor, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Main Objective is to Compare the Level of Anxiety in the Experimental Arm With the Control Arm at 6 Months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.