Feasibility Study CORPPS

Study Overview
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Brief Summary
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The incidence of cancer in France has increased by +135% to reach nearly 400,000 new cases in 2018. The ten-year cancer control strategy 2021-2030 and the health innovation plan have defined strategic axes. Almost all of these axes are addressed in our project. Firstly, the main objective of our study is to improve the quality of life of patients. Secondly, pharyngolaryngeal and oesophageal cancers are among the cancers with a poor prognosis in adults. Thirdly, the project provides access to personalised supportive care for all patients at all times. Finally, the secondary objectives of this study are the prevention of post-operative complications (infectious, thrombo-embolic, pain...).

Official Title
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FEASIBILITY STUDY on the Use of a DIGITAL PLATFORM for Physical and Psychosocial RECONDITION After Major Neoplastic Surgery

Conditions
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Esophageal Neoplasm, Laryngeal Neoplasms

Intervention / Treatment
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* Device: Digital platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized for initial surgical management of esophageal or laryngeal cancer Admitted to a conventional ward after partial oesophagectomy or total laryngectomy in a neoplastic setting Patient giving consent to participate in the study Affiliated to the compulsory health insurance scheme, regardless of the scheme Exclusion Criteria: Patient who did not follow the previously described course of care prior to admission to the ward Esophagectomy with total circular pharyngo-laryngectomy Total esogastrectomy Illiterate, visually impaired patient Minor, or adult under guardianship or curatorship, under judicial protection, person deprived of liberty

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Digital platform|The digital platform consists of 84 exercise sessions of progressive intensity. Each day, the tool offers 8 exercise sessions of about 5 to 10 minutes each, spaced out over an hour. One session can represent several exercises. The patient is asked to perform them daily.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability rate | Realization of the ratio between the number of inclusion proposals and the number of accepted inclusions. | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to exercise intervention program: Number of login |  | Discharge from hospital if it occurs before 30 days or at Day 30 | 
| Adherence to exercise intervention program: Number of exercises completed |  | Discharge from hospital if it occurs before 30 days or at Day 30 | 
| Adherence to exercise intervention program: type of exercises completed |  | Discharge from hospital if it occurs before 30 days or at Day 30 | 
| Adherence to exercise intervention program: retention rate |  | Discharge from hospital if it occurs before 30 days or at Day 30 | 
| Satisfaction by the System Usability Scale |  | Discharge from hospital if it occurs before 30 days or at Day 30 | 
| Classification de Clavien-Dindo | Evaluation of the incidence of postoperative complications based on the Clavien-Dindo classification grade II | At day 30 | 
| Visual Analogue Scale | Measure the pain in the scale from 0 to 10 | Before and after each activity | 
| Instant Well-Being Evaluation (IWBE) | It consists of a graduated scale: the patient must position a cursor, the position on the left corresponding to I feel very well and the position on the right to I do not feel well. The patient is guided by a pictogram (happy, neutral or sad face) | Baseline, Discharge from hospital if it occurs before 30 days and at Day 30 | 
| Warwick-Edinburgh Mental Wellbeing Scales | The well-being and theu quality of life will be assessed using the Warwick-Edinburgh Mental Wellbeing Scales Each item is scored on a range from 1 to 5. The total score will be between 14 and 70, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 45. A substantial decrease in wellbeing is a decrease by 5 or more points. | Baseline, Discharge from hospital if it occurs before 30 days and at Day 30 | 
| EuroQuol 5 Dimensions (EQ-5D-5L) | The quality of life will be assessed using the EuroQuol 5 Dimensions The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale [VAS]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status. | Baseline, Discharge from hospital if it occurs before 30 days and at Day 30 | 
| European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaires (EORTC-QLQ-C30) | The quality of life will be assessed using the EORTC-QLQ-C30 The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many clinical trials in oncology | Baseline, Discharge from hospital if it occurs before 30 days and at Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Physical and psychosocial rehabilitation, Digital platform, Esophagectomy, Laryngectomy