← Back to all trials
Withdrawn
NCT06485310
Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients With a Primary Malignancy of the Central Nervous System
Conditions: Central Nervous System Cancer, Psychological Distress
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Sponsor: Centre Hospitalier Universitaire de la Réunion
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.
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
Source: ClinicalTrials.gov (NCT06485310). StuddyBuddy aggregates publicly available trial information.