Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients With a Primary Malignancy of the Central Nervous System
TECAP
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedStudy Start
First participant enrolled
March 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
January 20, 2026
January 1, 2026
2 years
June 26, 2024
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Distress thermometer
Comparison of the change in psychological distress score, measured using the psychological distress screening tool (from National Comprehensive Cancer Network) between the 2 groups between inclusion (T0) and before the first anti-cancer therapy (T1).
10 days
Study Arms (2)
TELECONSULTATION
EXPERIMENTALTeleconsultation 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.
NO TELECONSULTATION
NO INTERVENTIONThe control group will be cared for according to standard practice (without teleconsultation)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Reunion Island - Neurosurgery department
Saint-Pierre-des-Corps, Reunion, 97410, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2024
First Posted
July 3, 2024
Study Start
March 31, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share