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CompletedNCT05406024FAISA-CORPPSUpdated Dec 11, 2025

Feasibility Study CORPPS

An observational study in Esophageal Neoplasm and Laryngeal Neoplasms, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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...).

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Conditions studied

  • Esophageal Neoplasm
  • Laryngeal Neoplasms

Keywords

  • Cancer
  • Physical and psychosocial rehabilitation
  • Digital platform
  • Esophagectomy
  • Laryngectomy
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 30 is below the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

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.

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What researchers measure

Primary outcomes

  1. Acceptability rate

    Realization of the ratio between the number of inclusion proposals and the number of accepted inclusions.

    Time frame: At 1 year

Secondary outcomes

  1. Adherence to exercise intervention program: Number of login

    Time frame: Discharge from hospital if it occurs before 30 days or at Day 30

  2. Adherence to exercise intervention program: Number of exercises completed

    Time frame: Discharge from hospital if it occurs before 30 days or at Day 30

  3. Adherence to exercise intervention program: type of exercises completed

    Time frame: Discharge from hospital if it occurs before 30 days or at Day 30

  4. Adherence to exercise intervention program: retention rate

    Time frame: Discharge from hospital if it occurs before 30 days or at Day 30

  5. Satisfaction by the System Usability Scale

    Time frame: Discharge from hospital if it occurs before 30 days or at Day 30

  6. Classification de Clavien-Dindo

    Evaluation of the incidence of postoperative complications based on the Clavien-Dindo classification grade II

    Time frame: At day 30

  7. Visual Analogue Scale

    Measure the pain in the scale from 0 to 10

    Time frame: Before and after each activity

  8. 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)

    Time frame: Baseline, Discharge from hospital if it occurs before 30 days and at Day 30

  9. 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.

    Time frame: Baseline, Discharge from hospital if it occurs before 30 days and at Day 30

  10. 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.

    Time frame: Baseline, Discharge from hospital if it occurs before 30 days and at Day 30

  11. 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

    Time frame: Baseline, Discharge from hospital if it occurs before 30 days and at Day 30

07

Study locations

1 site
  • Centre Hospitalier Universtaire
    Lille, 59037, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05406024
Lead sponsor
University Hospital, Lille
Collaborators
Santelys Association, ENGIE, Fondation Boulanger
Responsible party
Sponsor
First posted
Jun 6, 2022
Start date
Apr 3, 2023
Primary completion
Apr 19, 2024
Completion
Apr 19, 2024
Last update
Dec 11, 2025

Study contacts

Guillaume Piessen, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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