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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Supportive care | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 :
During these consultations, several scales will be performed to assess the patient's condition (anxiety, nutritional status, psychological condition, speech therapy status). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month ; 3 months ; 6 months |
| pain evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camille Vuarin, APN | Contact | +33 2 98 34 20 31 | 552031 | cvuarin@chp-brest.bzh |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pasteur Lanroze | Recruiting | Brest | 29000 | France |
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| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D000094783 | Paramedics |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D000488 | Allied Health Personnel |
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Pain will be assessed using a visual analogue scale from 0 (no pain) to 10 (worst pain imaginable). |
| 1 month ; 3 months ; 6 months |
| 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. | 1 month ; 3 months ; 6 months |
| Weight status evaluation | Weight statut will be determined by calculating the body mass index (BMI) and the percentage of loss weight. | 1 month ; 3 months ; 6 months |
| nutritional status evaluation | 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"). | 1 month ; 3 months ; 6 months |
| swallowing assessment | 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". | 1 month ; 3 months ; 6 months |
| vocal status assessment | Vocal status is measured by Vocal Handicap Index (VHI). It is a questionnaire with 30 questions with a Likert scale from "never" to "always". | 1 month ; 3 months ; 6 months |
| D001523 |
| Mental Disorders |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |