Support Pathway for ENT Cancer Patients in a Support Care Day Hospital Single-centre Prospective Randomised Interventional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Clinique Pasteur Lanroze
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Anxiety
Study Overview
Brief 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.
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
- •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
Arms & Interventions
Control
Supportive care
Intervention: Consultations with paramedics (Procedure)
Outcomes
Primary Outcomes
Anxiety
Time Frame: 1 month ; 3 months ; 6 months
Anxiety evaluation by State Trait Anxiety Inventory (STAI) scale. It is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety.
Secondary Outcomes
- Quality of life evaluation(1 month ; 3 months ; 6 months)
- pain evaluation(1 month ; 3 months ; 6 months)
- Toxic behaviour (tobacco and alcohol) evaluation(1 month ; 3 months ; 6 months)
- Weight status evaluation(1 month ; 3 months ; 6 months)
- nutritional status evaluation(1 month ; 3 months ; 6 months)
- swallowing assessment(1 month ; 3 months ; 6 months)
- vocal status assessment(1 month ; 3 months ; 6 months)