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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06485310
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Hospitalier Universitaire de la Réunion
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Central Nervous System Cancer, Psychological Distress

Additional Details

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

Arms & Interventions

Arms

Experimental: 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.

No Intervention: NO TELECONSULTATION

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

Interventions

Other: - Teleconsultation for psychological support

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

St Pierre, Reunion, France

Status

Address

University Hospital of Reunion Island - Neurosurgery department

St Pierre, Reunion, 97410

Site Contact

Stephanie FAIDERBE, nurse

[email protected]

0262 262 35 91 31

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