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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Другое 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

Первичные конечные точки

• Distress thermometer [Срок оценки: 10 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• University Hospital of Reunion Island - Neurosurgery department — Saint-Pierre-des-Corps

Идентификаторы

NCT: NCT06485310 · 2024/CHU/02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗