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

NCT06512662 | Recruiting

• 1 other identifier: 2023-18-CPL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Otorhinolaryngologic Neoplasms

Keywords

surgery; quality of life; anxiety; supportive care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Quality of life evaluation

  1 month ; 3 months ; 6 months

• pain evaluation

  1 month ; 3 months ; 6 months

• Toxic behaviour (tobacco and alcohol) evaluation

  1 month ; 3 months ; 6 months

• Weight status evaluation

  1 month ; 3 months ; 6 months

• nutritional status evaluation

  1 month ; 3 months ; 6 months

Study Arms (2)

Control

NO INTERVENTION

Supportive care

EXPERIMENTAL

Procedure: Consultations with paramedics

Interventions

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).

Supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Pasteur Lanroze: lead

Study Sites (1)

Clinique Pasteur Lanroze

Brest, 29000, France

RECRUITING

MeSH Terms

Conditions

Otorhinolaryngologic Neoplasms; Anxiety Disorders

Interventions

Referral and Consultation; Paramedics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Central Study Contacts

Camille Vuarin, APN

CONTACT

+33 2 98 34 20 31; cvuarin@chp-brest.bzh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: October 8, 2024
• Primary Completion: October 31, 2025
• Study Completion: March 31, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)