Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485310
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients With a Primary Malignancy of the Central Nervous System
Sponsor:
Centre Hospitalier Universitaire de la Réunion
Organization:
Centre Hospitalier Universitaire de la Réunion
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TECAP
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 D024 das nursing teleconsultation for psychological support
Groups A and B D010days telephone call to complete the same 4 questionnaires as at inclusion
Group A D015days semi-directive interview at home for voluntary patients
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 D024 das nursing teleconsultation for psychological support
Groups A and B D010days telephone call to complete the same 4 questionnaires as at inclusion
Group A D015days 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None