Support Pathway for ENT Cancer Patients in a Support Care Day Hospital
- Conditions
- Otorhinolaryngologic Neoplasms
- Interventions
- Procedure: Consultations with paramedics
- Registration Number
- NCT06512662
- Lead Sponsor
- Clinique Pasteur Lanroze
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supportive care Consultations with paramedics -
- Primary Outcome Measures
Name Time Method Anxiety 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 Outcome Measures
Name Time Method Quality of life evaluation 1 month ; 3 months ; 6 months Quality of life will be evaluated by EORTC C30. The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.
pain evaluation 1 month ; 3 months ; 6 months Pain will be assessed using a visual analogue scale from 0 (no pain) to 10 (worst pain imaginable).
Toxic behaviour (tobacco and alcohol) evaluation 1 month ; 3 months ; 6 months Tobacco (number of cigarettes per day) and alcohol (number of units per day) consumption will be evaluated by questioning the patient.
Weight status evaluation 1 month ; 3 months ; 6 months Weight statut will be determined by calculating the body mass index (BMI) and the percentage of loss weight.
nutritional status evaluation 1 month ; 3 months ; 6 months Nutritional status will be evaluated using SEFI (simple evaluation of food intake) scale. This scale is a Likert scale to assess the portion eaten at mealtimes, from 0 ("I haven't eaten anything") to 10 ('I have eaten everything").
swallowing assessment 1 month ; 3 months ; 6 months Swallowing is measured by Deglutition Handicap Index (DHI). It is a questionnaire with 30 questions (10 physical, 10 functional, 10 emotional) with a Likert scale from "never" to "always".
vocal status assessment 1 month ; 3 months ; 6 months Vocal status is measured by Vocal Handicap Index (VHI). It is a questionnaire with 30 questions with a Likert scale from "never" to "always".
Trial Locations
- Locations (1)
Clinique Pasteur Lanroze
🇫🇷Brest, France