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Trial Title:
Support Pathway for ENT Cancer Patients in a Support Care Day Hospital
NCT ID:
NCT06512662
Condition:
Otorhinolaryngologic Neoplasms
Conditions: Official terms:
Otorhinolaryngologic Neoplasms
Conditions: Keywords:
surgery
quality of life
anxiety
supportive care
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Consultations with paramedics
Description:
Patients of experimental arm will beneficiate of supplemental consultations with
paramedics intervenants at 1 month, 3 months and 6 months after surgery :
- dietetician
- speech therapist
- psychologist
- advanced practice nurse
During these consultations, several scales will be performed to assess the patient's
condition (anxiety, nutritional status, psychological condition, speech therapy status).
Arm group label:
Supportive care
Summary:
Cancers of the upper respiratory / digestive tract are a major public health problem,
ranking 5th among the most common cancers. Surgery plays a central role in the
recommended treatments for this type of pathology. The surgical procedure and its
after-effects can be anxiety-provoking and have a major psychological, physical and
social impact on patients over the long term.
Our institution's standard protocol is based on a pre-operative supportive care day
hospital. The aim of this study is to compare our current care pathway with a more
extensive interdisciplinary care pathway focused on patients' needs, in order to reduce
anxiety and improve the quality of life of patients undergoing surgery for cancers of the
upper respiratory / digestive tract.
Our aim is to use a prospective single-centre interventional study to assess the impact
of adding three post-operative day hospitals to the existing care pathway in terms of
reducing anxiety and improving the quality of life of patients undergoing surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patient undergoing surgery for VADS cancer requiring at least one night's
post-operative hospitalisation
- Understanding of spoken and written French
- Patient covered by a social security scheme
Exclusion Criteria:
- Protected patient under a protective measure or legal safeguard
- Pregnant or breast-feeding patients
- Patients suffering from major cognitive disorders
- Patients with major anxiety disorders prior to the onset of cancer
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique Pasteur Lanroze
Address:
City:
Brest
Zip:
29000
Country:
France
Status:
Recruiting
Contact:
Last name:
Anthony Monnier
Phone:
+33 2 98 31 33 51
Email:
amonnier@chp-brest.bzh
Start date:
October 8, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Clinique Pasteur Lanroze
Agency class:
Other
Source:
Clinique Pasteur Lanroze
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06512662
