Clinical trial NCT05406024: Feasibility Study CORPPS
Official title: FEASIBILITY STUDY on the Use of a DIGITAL PLATFORM for Physical and Psychosocial RECONDITION After Major Neoplastic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Neoplasm
Laryngeal Neoplasms
Keywords: Cancer
Physical and psychosocial rehabilitation
Digital platform
Esophagectomy
Laryngectomy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Santelys Association
name: ENGIE
name: Fondation Boulanger
First posted: 2022-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients hospitalized for surgical management of esophageal or laryngeal cancer in Lille University Hospital

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...).


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability rate
timeFrame: At 1 year
Secondary outcomes:
measure: Adherence to exercise intervention program: Number of login
timeFrame: Discharge from hospital if it occurs before 30 days or at Day 30
measure: Adherence to exercise intervention program: Number of exercises completed
timeFrame: Discharge from hospital if it occurs before 30 days or at Day 30
measure: Adherence to exercise intervention program: type of exercises completed
timeFrame: Discharge from hospital if it occurs before 30 days or at Day 30
measure: Adherence to exercise intervention program: retention rate
timeFrame: Discharge from hospital if it occurs before 30 days or at Day 30
measure: Satisfaction by the System Usability Scale
timeFrame: Discharge from hospital if it occurs before 30 days or at Day 30
measure: Classification de Clavien-Dindo
timeFrame: At day 30
measure: Visual Analogue Scale
timeFrame: Before and after each activity
measure: Instant Well-Being Evaluation (IWBE)
timeFrame: Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
measure: Warwick-Edinburgh Mental Wellbeing Scales
timeFrame: Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
measure: EuroQuol 5 Dimensions (EQ-5D-5L)
timeFrame: Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
measure: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaires (EORTC-QLQ-C30)
timeFrame: Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Piessen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: