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Recruiting NCT06512662

Support Pathway for ENT Cancer Patients in a Support Care Day Hospital

No phase Interventional Otorhinolaryngologic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Consultations with paramedics.
Who it may be relevant to
Registry conditions: Otorhinolaryngologic Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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).

Primary outcome measures

  • Anxiety [Time frame: 1 month ; 3 months ; 6 months]
Secondary outcome measures (7)
  • Quality of life evaluation [Time frame: 1 month ; 3 months ; 6 months]
  • pain evaluation [Time frame: 1 month ; 3 months ; 6 months]
  • Toxic behaviour (tobacco and alcohol) evaluation [Time frame: 1 month ; 3 months ; 6 months]
  • Weight status evaluation [Time frame: 1 month ; 3 months ; 6 months]
  • nutritional status evaluation [Time frame: 1 month ; 3 months ; 6 months]
  • swallowing assessment [Time frame: 1 month ; 3 months ; 6 months]
  • vocal status assessment [Time frame: 1 month ; 3 months ; 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Clinique Pasteur Lanroze — Brest

Identifiers

NCT: NCT06512662 · 2023-18-CPL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗