Clinical trial NCT06485310: Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients with a Primary Malignancy of the Central Nervous System
Official title: Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients with a Primary Malignancy of the Central Nervous System Between the Announcement of the Diagnosis and the First Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Central Nervous System Cancer
Psychological Distress
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

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

Primary outcomes:
measure: Distress thermometer
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: St Pierre
country: France
facility: University Hospital of Reunion Island - Neurosurgery department
state: Reunion
Study officials:
References: