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NCT Number: NCT06485310

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Reunion Island - Neurosurgery department

Saint-Pierre-des-Corps, Reunion, 97410, France

Location contact

Stephanie FAIDERBE, nurse

CONTACT

[email protected]

0262 262 35 91 31

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teleconsultation for psychological support

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

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Stephanie FAIDERBE, Nurse

CONTACT

[email protected]

0262 262 35 91 31

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

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

Acronym: TECAP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 3, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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