Support Pathway for ENT Cancer Patients in a Support Care Day Hospital
ConditionOtorhinolaryngologic Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Pasteur Lanroze
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Consultations with paramedics
Procedure/SurgeryPatients 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).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Supportive careExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 month ; 3 months ; 6 monthsSecondary outcomes
1
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.
Time frame
1 month ; 3 months ; 6 months2
pain evaluation
Pain will be assessed using a visual analogue scale from 0 (no pain) to 10 (worst pain imaginable).
Time frame
1 month ; 3 months ; 6 months3
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.
Time frame
1 month ; 3 months ; 6 months4
Weight status evaluation
Weight statut will be determined by calculating the body mass index (BMI) and the percentage of loss weight.
Time frame
1 month ; 3 months ; 6 monthsSponsors and contacts
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Source ClinicalTrials.gov