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Clinical Trials/NCT06485310
NCT06485310
Not yet recruiting
Not Applicable

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

Centre Hospitalier Universitaire de la Réunion1 site in 1 country58 target enrollmentMarch 31, 2026

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Nervous System Cancer
Sponsor
Centre Hospitalier Universitaire de la Réunion
Enrollment
58
Locations
1
Primary Endpoint
Distress thermometer
Status
Not yet recruiting
Last Updated
3 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 31, 2026
End Date
June 30, 2028
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Distress thermometer

Time Frame: 10 days

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).

Study Sites (1)

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