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

Centre Hospitalier Universitaire de la Réunion

Status: Begins enrollment in 1 month

Conditions: Central Nervous System Cancer; Psychological Distress

Treatments: Other: Teleconsultation for psychological support

Study type: Interventional

Funder types: Other

Identifiers

NCT06485310

2024/CHU/02

Details and patient eligibility

About

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.

Full 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

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

TELECONSULTATION

Experimental group

Description:

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.

Treatment:

Other: Teleconsultation for psychological support

NO TELECONSULTATION

No Intervention group

Description:

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