Clinical trial · Interventional
Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients With a Primary Malignancy of the Central Nervous System
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Why stopped (as posted): The principal investigator has left the research center.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Cancer | Malignant Central Nervous System Neoplasm | ALIAS | 0.90 |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Teleconsultation for psychological support | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TELECONSULTATION
- 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.
- interventionNames
- Other: Teleconsultation for psychological support
- type
- NO_INTERVENTION
- label
- NO TELECONSULTATION
- description
- The control group will be cared for according to standard practice (without teleconsultation)
Primary outcomes (1)
- measure
- Distress thermometer
- timeFrame
- 10 days
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available