Support Pathway for ENT Cancer Patients in a Support Care Day Hospital (PAKO-HDJ)

Support Pathway for ENT Cancer Patients in a Support Care Day Hospital Single-centre Prospective Randomised Interventional Study

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 Overview

• Status: Recruiting
• Conditions: Otorhinolaryngologic Neoplasms
• Intervention / Treatment: Procedure: Consultations with paramedics

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camille Vuarin, APN; Phone Number: 552031 +33 2 98 34 20 31; Email: cvuarin@chp-brest.bzh

Study Locations

• France
  • Brest, France, 29000
    • Recruiting
    • Clinique Pasteur Lanroze
    • Contact: Anthony Monnier; Phone Number: +33 2 98 31 33 51; Email: amonnier@chp-brest.bzh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Supportive care	Procedure: Consultations 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Clinique Pasteur Lanroze

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; surgery; anxiety; supportive care
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Anxiety Disorders; Otorhinolaryngologic Neoplasms; Professional Practice; Organization and Administration; Health Services Administration; Health Care Facilities Workforce and Services; Health Personnel; Allied Health Personnel; Referral and Consultation; Paramedics
• Other Study ID Numbers: 2023-18-CPL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No