Feasibility Study CORPPS (FAISA-CORPPS)

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

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...).

Study Overview

• Status: Completed
• Conditions: Laryngeal Neoplasms; Esophageal Neoplasm
• Intervention / Treatment: Device: Digital platform

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Centre Hospitalier Universtaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients hospitalized for surgical management of esophageal or laryngeal cancer in Lille University Hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Santelys Association; ENGIE; Fondation Boulanger
• Investigators: Principal Investigator: Guillaume Piessen, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Esophagectomy; Laryngectomy; Physical and psychosocial rehabilitation; Digital platform
• Additional Relevant MeSH Terms: Neoplasms by Site; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Respiratory Tract Neoplasms; Esophageal Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Neoplasms; Esophageal Neoplasms; Laryngeal Neoplasms
• Other Study ID Numbers: 2021_0215; 2021-A02644-37 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No