Otorhinolaryngologic Neoplasms
Conditions
Keywords
surgery, quality of life, anxiety, supportive care
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.
Interventions
PROCEDUREConsultations with paramedics
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).
Sponsors
Clinique Pasteur Lanroze
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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". |
Countries
France
Contacts
CONTACTCamille Vuarin, APN
Outcome results
None listed