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

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2028-06-30

Brief Summary

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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

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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

Conditions

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Central Nervous System Cancer Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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TELECONSULTATION

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.

Group Type EXPERIMENTAL

Teleconsultation for psychological support

Intervention Type OTHER

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

NO TELECONSULTATION

The control group will be cared for according to standard practice (without teleconsultation)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Teleconsultation for psychological support

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Reunion Island - Neurosurgery department

Saint-Pierre-des-Corps, Reunion, France

Site Status

Countries

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France

Central Contacts

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Stephanie FAIDERBE, Nurse

Role: CONTACT

0262 262 35 91 31

Facility Contacts

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Stephanie FAIDERBE, nurse

Role: primary

0262 262 35 91 31

Other Identifiers

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2024/CHU/02

Identifier Type: -

Identifier Source: org_study_id

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