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

NCT ID: NCT06512662

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Otorhinolaryngologic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Supportive care

Group Type EXPERIMENTAL

Consultations with paramedics

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Pasteur Lanroze

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Pasteur Lanroze

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Camille Vuarin, APN

Role: CONTACT

+33 2 98 34 20 31 ext. 552031

Facility Contacts

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Anthony Monnier

Role: primary

+33 2 98 31 33 51

Other Identifiers

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2023-18-CPL

Identifier Type: -

Identifier Source: org_study_id

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