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Trial Title:
Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients With a Primary Malignancy of the Central Nervous System
NCT ID:
NCT06485310
Condition:
Central Nervous System Cancer
Psychological Distress
Conditions: Official terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Teleconsultation for psychological support
Description:
Teleconsultation with a nurse for psychological support, after the diagnosis has been
announced, before hospitalization for the first treatment (chemotherapy, surgery,
radiotherapy) in addition to the standard practice
Arm group label:
TELECONSULTATION
Summary:
The goal of this clinal trial is to compare the effectiveness of nurse-led
teleconsultation with usual care (intervention group) on psychological distress in
patients with primary malignant tumors of the central nervous system between diagnosis
and first anti-cancer treatment, versus usual care alone (control group).
Participants will be randomized into two groups :
- group A) intervention: usual care + nurse teleconsultation for psychological support
- group B) control: usual care alone
Enrolment = Day0 (D0)
Participants will :
- groups A and B: D0: complete 4 questionnaires (Quality of Life, Screening for
Distress, Screening for Anxiety and Depression, Social Support Questionnaire)
- Group A : D0+2/4 das : nursing teleconsultation for psychological support
- Groups A and B: D0+10days : telephone call to complete the same 4 questionnaires as
at inclusion
- Group A : D0+15days: semi-directive interview, at home, for voluntary patients.
Detailed description:
The expected benefits are as follows:
For the patient :
- Reduction in pre-treatment psychological distress
- Reduced pre-treatment anxiety and depression
- Better understanding of disease and treatments
- Better adherence to the care proposed in the treatment pathway
- Reduced stress during first hospital treatment
For healthcare professionals :
- Early detection of psychological distress
- Early detection of unmet needs and appropriate individualized responses
- Establishment of a climate of trust between patient and caregiver
- Improved professional practices
For the healthcare system :
- Lower healthcare costs (fewer anxiolytic treatments, etc.)
- Therapy to be integrated into the treatment pathway of patients with central nervous
system cancer
- Reduced socio-territorial inequalities in healthcare provision
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- aged 18 and over
- being treated for a primary malignant tumor of the central nervous system (positive
biopsy)
- with a Mini-Mental State score greater than 24
- not receiving first-line treatment (chemotherapy, targeted radiotherapy, surgery)
- with a distress score above 3 on the Psychological Distress Thermometer
- have access to computer equipment equipped with a microphone and webcam (smartphone,
computer)
- able to read, write and speak French
- have given free and informed consent
- being affiliated to a social security scheme
Exclusion Criteria:
- with a history of psychiatric illness
- with recurrent cancer of the cerebral nervous system
- having begun first-line treatment (drug therapy, curative surgery, radiotherapy or
palliative care)
- under guardianship, curatorship or deprived of liberty
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital of Reunion Island - Neurosurgery department
Address:
City:
St Pierre
Zip:
97410
Country:
France
Status:
Recruiting
Contact:
Last name:
Stephanie FAIDERBE, nurse
Phone:
0262 262 35 91 31
Email:
stephanie.federbe@chu-reunion.fr
Start date:
December 24, 2024
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de la Réunion
Agency class:
Other
Source:
Centre Hospitalier Universitaire de la Réunion
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06485310
