Esophageal Neoplasm, Laryngeal Neoplasms
Conditions
Keywords
Cancer, Physical and psychosocial rehabilitation, Digital platform, Esophagectomy, Laryngectomy
Brief summary
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...).
Interventions
DEVICEDigital 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.
Sponsors
Santelys Association
ENGIE
Fondation Boulanger
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability rate | At 1 year | Realization of the ratio between the number of inclusion proposals and the number of accepted inclusions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Warwick-Edinburgh Mental Wellbeing Scales | Baseline, Discharge from hospital if it occurs before 30 days and at Day 30 | 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. |
| Visual Analogue Scale | Before and after each activity | Measure the pain in the scale from 0 to 10 |
| Instant Well-Being Evaluation (IWBE) | Baseline, Discharge from hospital if it occurs before 30 days and at Day 30 | 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) |
| EuroQuol 5 Dimensions (EQ-5D-5L) | Baseline, Discharge from hospital if it occurs before 30 days and at Day 30 | 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. |
| European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaires (EORTC-QLQ-C30) | Baseline, Discharge from hospital if it occurs before 30 days and at Day 30 | 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 |
| Classification de Clavien-Dindo | At day 30 | Evaluation of the incidence of postoperative complications based on the Clavien-Dindo classification grade II |
Countries
France
Outcome results
None listed