Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
Phase: NA
Conditions: Glial Tumor
Sponsor: Institut Cancerologie de l'Ouest

Short title : 
 
SOPHNEURO 
Ref ICO : 
 
ICO-2020-12 
N° IDRCB: 
 
2021-A02313-38 
NCT:                                       NCT05189366 
 
SOPHNEURO_brief protocol_V2.2 24.03.2026 
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Brief Protocol 
PROTOCOL SOPHNEURO 
 
A) IDENTIFICATION OF THE CLINICAL TRIAL 
TITLE OF THE TRIAL: 
Study evaluating the benefits of combining sophrology treatment with 
speech therapy for patients with glial tumours requiring speech therapy 
SHORT TITLE: 
SOPHNEURO 
COORDINATOR:  
Céline THOMAS 
METHODOLOGISTS : 
Dr Audrey BLANC-LAPIERRE and Julie PAUL 
ESTIMATED NUMBER OF 
CENTERS: 
1 (ICO Nantes and Angers) 
NUMBER OF 
SUBJECTS: 
40 
 
 
B) IDENTIFICATION OF THE SPONSOR 
SPONSOR: 
INSTITUT DE CANCEROLOGIE DE L’OUEST 
CONTACT: 
 
  
Marine TIGREAT 
Tél : +332 40 67 98 78 
 
 
C) RATIONALE 
Patients with brain tumors experience a loss of autonomy, which may occur suddenly or progressively. Communication 
with the patient can be rapidly impaired due to altered levels of consciousness, language disorders, and/or 
neurocognitive impairments. 
In addition to these clinical symptoms, patients frequently present with high levels of anxiety and depression as a result 
of the severity of the diagnosis, leading to a major impact on quality of life. 
Alongside standard oncological management, including surgery, radiotherapy, and chemotherapy, a multidisciplinary 
rehabilitation approach is recommended due to impairments related both to the pathology itself and to treatment-
related neurotoxicity. This rehabilitation may involve physical therapists, occupational therapists, speech and language 
therapists, neuropsychologists, among others. 
In this study, we will focus primarily on the subgroup of patients presenting with communication disorders, for whom 
speech and language therapy plays a key role. 
In order to better address anxiety—which is often difficult to verbalize due to communication impairments—sophrology 
may be proposed as an alternative to psychological support, which can be overly complex or poorly adapted in this 
population. 
Within the framework of integrative oncology, sophrology is considered a mind–body technique comparable to 
mindfulness meditation or hypnosis. Its aim is to positively enhance patients’ personal resources and abilities. It induces 
modified states of consciousness and enables individuals to achieve a balance between thoughts, emotions, and 
behaviors. 
If sophrology has a positive impact on patients’ emotional well-being, it may also lead to improvements in motor 
function, interpersonal relationships, and overall quality of life. 
After observing positive patient feedback following a combined speech therapy and sophrology intervention, this study 
aims to evaluate the benefits of integrating sophrology into the care of patients with glial tumors requiring speech and 
language therapy. 
Our hypotheses are that this combined approach may reduce anxiety levels, improve quality of life, and positively 
influence the outcomes of speech and language rehabilitation. 

Short title : 
 
SOPHNEURO 
Ref ICO : 
 
ICO-2020-12 
N° IDRCB: 
 
2021-A02313-38 
NCT:                                       NCT05189366 
 
SOPHNEURO_brief protocol_V2.2 24.03.2026 
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D) GENERAL INFORMATION ABOUT THE TRIAL 
POPULATION: 
Patients with grade II, III, and IV glial tumors requiring speech and language therapy. 
METHODOLOGY 
Randomized study (1:1), with stratification criteria: 
• 
Tumor grade: grade 2- 3 or grade 4 
• 
Type of surgery: excision or biopsy 
• 
PS: 0-1 or 2-3 
• 
Speech therapy started: yes or no 
MAIN OBJECTIVE: 
The primary objective is to compare the level of anxiety in the experimental arm with 
the control arm at 6 months. 
PRIMARY EVALUATION  
CRITERION: 
Primary endpoint is anxiety levels will be measured using the Hospital Anxiety and 
Depression Scale at 6 months in both treatment arms. 
SECONDARY OBJECTIVE: 
Secondary objectives are to evaluate: 
a) the impact of the practice of sophrology on the patient's quality of life. 
b) the impact of the practice of sophrology during speech therapy on the 
improvement of communication disorders; 
c) the effect of a sophrology session on anxiety; 
d) Level of anxiety in both arms at M0 and M3. 
SECONDARY EVALUATION  
CRITERION: 
Secondary endpoints are: 
a) Quality of life will be assessed using quality of life questionnaires at M0, M3 
and M6. These are the EORTC QLQ-C30 v3 questionnaire and the EORTCBN20 
brain-specific module; 
b) Improvement in communication disorders will be assessed by standard speech 
and language tests at M0, M3 and M6. These are standardized tests, adapted 
to the population, reproducible and validated by speech therapists; 
c) Anxiety will be assessed using the Visual Analog Scale (VAS) of anxiety and help 
before and after each sophrology session; 
d) The description of the level of anxiety in the two treatment arms at M0 and 
M3 will be carried out using the HADS. 
 
 
 

Short title : 
 
SOPHNEURO 
Ref ICO : 
 
ICO-2020-12 
N° IDRCB: 
 
2021-A02313-38 
NCT:                                       NCT05189366 
 
SOPHNEURO_brief protocol_V2.2 24.03.2026 
 Page 3 sur 6 
INCLUSION CRITERIA: 
1) Patients with histologically proven grade II, III and IV glial tumours requiring 
speech therapy; 
2) Patient willing to start and/or continue outpatient speech therapy; 
3) Patient aged 18 years and over; 
4) Informed patient who has signed consent; 
5) Patient affiliated to a social security scheme. 
EXCLUSION CRITERIA: 
1) Patient who has already had an initiation to sophrology in the context of his 
pathology; 
2) PS ≥ 4 ; 
3) Patients suffering from psychiatric disorders; delusional phases, schizophrenia 
against the practice of sophrology; 
4) Patient unable to follow the protocol (filling in questionnaires, attendance of 
sophrology and/or speech therapy sessions) for geographical, social or 
psychological reasons; 
5) Patients who do not speak French; 
6) Persons deprived of their liberty, under court protection, under curators or 
under the authority of a guardian; 
7) Women who are pregnant, likely to be pregnant or breastfeeding. 
 
E) DESCRIPTION OF THE STUDY INTERVENTIONS 
After randomization, patients who have signed a consent form receive the study procedures assigned to them. 
 

Short title : 
 
SOPHNEURO 
Ref ICO : 
 
ICO-2020-12 
N° IDRCB: 
 
2021-A02313-38 
NCT:                                       NCT05189366 
 
SOPHNEURO_brief protocol_V2.2 24.03.2026 
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CONTROL ARM : Arm A: Speech therapy 
Patients (control and experimental groups) will receive two speech therapy sessions per week for 6 months, lasting 
from 30 minutes to 1 hour, depending on the patient's general condition. 
The speech therapist will carry out a speech assessment to highlight the nature of the patient's disorders. This 
assessment is carried out at M0, M3 and M6. 
A session is divided into 3 parts. 
In the 1st part, the speech therapist will talk to the patient to discuss his or her state of health, his or her feelings about 
the previous session, and the compensatory strategies put in place during the previous session. 
In the second part, the speech therapist will begin the actual re-education, through a series of exercises based on a 
therapeutic plan (e.g. working memory with executive functions). 
Finally, the speech therapist will suggest an activity that the patient will be able to perform successfully, while 
reviewing the session and suggesting exercises to be carried out at home until the next session. 
ARM EXPERIMENTAL: Arm B : Speech therapy + Sophrology  
In the experimental arm, patients will benefit from 6 sessions of sophrology. Sessions are individual and last around 50 
minutes. During these sessions, the patient may be accompanied by a third party. 
The 1st sophrology session will take place at +/- 7 days from M0. Subsequent sessions are scheduled every 30 days, at 
+/- 7-day intervals.  
A sophrology protocol, i.e. a series of sessions, can be broken down into 3 key techniques: 
- SBV: Sophronisation de Base Vivantielle. This technique consists of adding mobilization or contraction of the body to 
facilitate perception. 
- PSL: Sophro-Liminal Protection. This technique involves associating an evocative word representing calm with the 
breath. 
- SPR: Sophro-Presence Relaxation. This technique consists in evoking “something” pleasant and putting as much detail 
as possible into it 
During the 1st session, a period of dialogue between the sophrologist and the patient will enable the latter's anamnesis 
to be taken. The sophrologist will then begin with the SBV technique. 
In subsequent sessions, the sophrologist will repeat the 1st SBV technique and complete it with the 2 other techniques, 
PSL and SPR.  
Before and after each session, the patient will be shown the Visual Analogue Scale for Anxiety and Help (VAS). 
Depending on the patient's state of health, sessions will be adapted and last between 30 and 45 min. 
INTERVENTION DURATION : 
6 months 
 
 
 

Short title : 
 
SOPHNEURO 
Ref ICO : 
 
ICO-2020-12 
N° IDRCB: 
 
2021-A02313-38 
NCT:                                       NCT05189366 
 
SOPHNEURO_brief protocol_V2.2 24.03.2026 
 Page 5 sur 6 
 
F) STATISTICAL CONSIDERATIONS 
DETERMINATION OF SAMPLE SIZE 
At the ICO, it is possible to include 40 patients per year with communication 
disorders. In a study including a control group of 19 patients with glioblastoma 
treated with hormonal therapy, chemotherapy and radiotherapy, a difference of 
1.73 points in the HADS score was observed after 4 months (PMID: 29892240). 
The intra-individual standard deviation (calculated from the paired t-test value 
indicated s=√𝑛*md/t) was approximately 3 points.  
 
The null hypothesis we wish to refute is that sophrology doesn't allow to show a 
difference in anxiety after 6 months (H0: md = 0). The inclusion of 20 patients per 
arm (i.e. 40 in total) will enable us to highlight, with an alpha risk of 5%, two-
sided, and a power of 85%, a difference of 3 points at 6 months between the 2 
groups compared. 
STATISTICAL AND ANALYTICAL PLANS:  
Descriptive analysis of the study population 
Categorial variables will be presented in terms of the number and associated 
percentage of each modality of the variable. Quantitative variables are described 
by mean and standard deviation or median, minimum and maximum, where 
applicable. The number of missing data is presented for each variable studied. 
 
Analysis of primary endpoint  
The level of anxiety (HADS) at M6 will be compared between the two groups 
using a Welch's test or a Mann-Whitney test (in case of non-Gaussian distribution 
of the variable). 
 
Analysis of secondary endpoints 
Quantitative variables will be compared between the two groups using a Welch's 
test or a Mann-Whitney test (in case of non-Gaussian distribution of the variable). 
Qualitative variables will be compared between the two groups using a Chi2 test 
or a Fisher test (in the case of theoretical numbers less than 5). 
 
 
 
 

Short title : 
 
SOPHNEURO 
Ref ICO : 
 
ICO-2020-12 
N° IDRCB: 
 
2021-A02313-38 
NCT:                                       NCT05189366 
 
SOPHNEURO_brief protocol_V2.2 24.03.2026 
 Page 6 sur 6 
 
 
G) TRIAL SCHEDULE 
INCLUSION PERIOD: 
36 months 
INTERVENTION DURATION : 
6 months 
FOLLOW-UP PERIOD :  
NA 
OVERALL STUDY DURATION: 
42 months