Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients With a Primary Malignancy of the Central Nervous System (TECAP)

January 16, 2026 updated by: Centre Hospitalier Universitaire de la Réunion

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Reunion
      • Saint-Pierre-des-Corps, Reunion, France, 97410
        • University Hospital of Reunion Island - Neurosurgery department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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
No Intervention: NO TELECONSULTATION
The control group will be cared for according to standard practice (without teleconsultation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/CHU/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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