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NCT Number: NCT06512662

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

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.

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Key information

Conditions

Otorhinolaryngologic Neoplasms Anxiety Disorders Head and Neck Neoplasms Mental Disorders Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consultations with paramedics

Procedure

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 outcomes

  1. Anxiety

    Time frame: 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 outcomes

  1. Quality of life evaluation

    Time frame: 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.

  2. pain evaluation

    Time frame: 1 month ; 3 months ; 6 months

    Pain will be assessed using a visual analogue scale from 0 (no pain) to 10 (worst pain imaginable).

  3. Toxic behaviour (tobacco and alcohol) evaluation

    Time frame: 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.

  4. Weight status evaluation

    Time frame: 1 month ; 3 months ; 6 months

    Weight statut will be determined by calculating the body mass index (BMI) and the percentage of loss weight.

  5. nutritional status evaluation

    Time frame: 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").

  6. swallowing assessment

    Time frame: 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".

  7. vocal status assessment

    Time frame: 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".

Study contacts

Contact information is provided by the study sponsor or research team.

Camille Vuarin, APN

CONTACT

[email protected]

+33 2 98 34 20 31 ext. 552031

Sponsors and collaborators

Lead sponsor

Clinique Pasteur Lanroze

Other

Registry information

Official study title

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

Acronym: PAKO-HDJ

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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