Support Pathway for ENT Cancer Patients in a Support Care Day Hospital
NCT Number: NCT06512662
Acronym: PAKO-HDJ
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Otorhinolaryngologic Neoplasms
Interventions: PROCEDURE: Consultations with paramedics
Sponsor: Clinique Pasteur Lanroze
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2026-03-31
Locations: Clinique Pasteur Lanroze, Brest, 29000, France

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.

Primary Outcome Measures: Anxiety, 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., 1 month ; 3 months ; 6 months
Secondary Outcome Measures: Quality of life evaluation, 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., 1 month ; 3 months ; 6 months|pain evaluation, Pain will be assessed using a visual analogue scale from 0 (no pain) to 10 (worst pain imaginable)., 1 month ; 3 months ; 6 months|Toxic behaviour (tobacco and alcohol) evaluation, Tobacco (number of cigarettes per day) and alcohol (number of units per day) consumption will be evaluated by questioning the patient., 1 month ; 3 months ; 6 months|Weight status evaluation, Weight statut will be determined by calculating the body mass index (BMI) and the percentage of loss weight., 1 month ; 3 months ; 6 months|nutritional status evaluation, 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")., 1 month ; 3 months ; 6 months|swallowing assessment, 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"., 1 month ; 3 months ; 6 months|vocal status assessment, Vocal status is measured by Vocal Handicap Index (VHI). It is a questionnaire with 30 questions with a Likert scale from "never" to "always"., 1 month ; 3 months ; 6 months