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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Distress thermometer
Study Overview
Brief Summary
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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Teleconsultation for psychological support (Other)
NO TELECONSULTATION
The control group will be cared for according to standard practice (without teleconsultation)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported