Feasibility Study CORPPS (FAISA-CORPPS)

December 4, 2025 updated by: University Hospital, Lille

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability rate
Time Frame: At 1 year
Realization of the ratio between the number of inclusion proposals and the number of accepted inclusions.
At 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to exercise intervention program: Number of login
Time Frame: Discharge from hospital if it occurs before 30 days or at Day 30
Discharge from hospital if it occurs before 30 days or at Day 30
Adherence to exercise intervention program: Number of exercises completed
Time Frame: Discharge from hospital if it occurs before 30 days or at Day 30
Discharge from hospital if it occurs before 30 days or at Day 30
Adherence to exercise intervention program: type of exercises completed
Time Frame: Discharge from hospital if it occurs before 30 days or at Day 30
Discharge from hospital if it occurs before 30 days or at Day 30
Adherence to exercise intervention program: retention rate
Time Frame: Discharge from hospital if it occurs before 30 days or at Day 30
Discharge from hospital if it occurs before 30 days or at Day 30
Satisfaction by the System Usability Scale
Time Frame: Discharge from hospital if it occurs before 30 days or at Day 30
Discharge from hospital if it occurs before 30 days or at Day 30
Classification de Clavien-Dindo
Time Frame: At day 30
Evaluation of the incidence of postoperative complications based on the Clavien-Dindo classification grade II
At day 30
Visual Analogue Scale
Time Frame: Before and after each activity
Measure the pain in the scale from 0 to 10
Before and after each activity
Instant Well-Being Evaluation (IWBE)
Time Frame: 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)
Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
Warwick-Edinburgh Mental Wellbeing Scales
Time Frame: 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.
Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
EuroQuol 5 Dimensions (EQ-5D-5L)
Time Frame: 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.
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)
Time Frame: 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
Baseline, Discharge from hospital if it occurs before 30 days and at Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Santelys Association
ENGIE
Fondation Boulanger

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillaume Piessen, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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