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Completed

NCT Number: NCT05406024

Feasibility Study CORPPS

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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Key information

Conditions

Esophageal Neoplasm Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universtaire

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital platform

Device

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.

Primary outcomes

  1. Acceptability rate

    Time frame: At 1 year

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

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

    Time frame: At day 30

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

  7. Visual Analogue Scale

    Time frame: Before and after each activity

    Measure the pain in the scale from 0 to 10

  8. 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)

  9. 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.

  10. 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.

  11. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • ENGIE
  • Fondation Boulanger
  • Santelys Association

Registry information

Official study title

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

Acronym: FAISA-CORPPS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2022
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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