Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy (SOPHNEURO)
Primary Purpose
Glial Tumor
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sophrology
Speech therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Glial Tumor focused on measuring Sophrology, Speech therapy
Eligibility 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;
Sites / Locations
- Institut de Cancérologie de l'OuestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental arm : Speech therapy + Sophrology
Control arm : Speech therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The secondary objective is to evaluate the impact of the practice of sophrology on the patient's quality of life
Quality of life will be assessed by quality of life questionnaires at baseline and after 3 and 6 months of treatment. These are the QLQ-C30 v3 questionnaire and the brain-specific module EORTC-BN20 ;
Full Information
NCT ID
NCT05189366
First Posted
December 28, 2021
Last Updated
July 31, 2023
Sponsor
Institut Cancerologie de l'Ouest
1. Study Identification
Unique Protocol Identification Number
NCT05189366
Brief Title
Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
Acronym
SOPHNEURO
Official Title
Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glial Tumor
Keywords
Sophrology, Speech therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm : Speech therapy + Sophrology
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm : Speech therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sophrology
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Speech therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The main objective is to compare the level of anxiety in the experimental arm with the control arm at 6 months.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The secondary objective is to evaluate the impact of the practice of sophrology on the patient's quality of life
Description
Quality of life will be assessed by quality of life questionnaires at baseline and after 3 and 6 months of treatment. These are the QLQ-C30 v3 questionnaire and the brain-specific module EORTC-BN20 ;
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CELINE THOMAS
Phone
+33 240679900
Ext
+33
Email
celine.thomas@ico.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
MARINE TIGREAT
Phone
+33 240679878
Ext
+33
Email
marine.tigreat@ico.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CELINE THOMAS
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CELINE THOMAS
Phone
+33 240679900
Ext
+33
Email
celine.thomas@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
MARINE TIGREAT
Phone
+33 240679878
Ext
+33
Email
marine.tigreat@ico.unicancer.fr
12. IPD Sharing Statement
Learn more about this trial
Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy
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