Esophageal NeoplasmFAISA-CORPPSNCT05406024
Feasibility Study CORPPS
An observational study of Esophageal Neoplasm and Laryngeal Neoplasms, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasm, Laryngeal Neoplasms
- What is being tested?
- Digital platform
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2023to 19 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized for surgical management of esophageal or laryngeal cancer in Lille University Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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...).
- Conditions
- Esophageal Neoplasm, Laryngeal Neoplasms
- Being tested
- Digital platform
- Keywords
- Cancer, Physical and psychosocial rehabilitation, Digital platform, Esophagectomy, Laryngectomy
- Medical subject headings
- Esophageal Neoplasms, Laryngeal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital platformDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability rate
Realization of the ratio between the number of inclusion proposals and the number of accepted inclusions.
Measured: At 1 year
Secondary outcomes (11)
Adherence to exercise intervention program: Number of login
Measured: Discharge from hospital if it occurs before 30 days or at Day 30
Adherence to exercise intervention program: Number of exercises completed
Measured: Discharge from hospital if it occurs before 30 days or at Day 30
Adherence to exercise intervention program: type of exercises completed
Measured: Discharge from hospital if it occurs before 30 days or at Day 30
Adherence to exercise intervention program: retention rate
Measured: Discharge from hospital if it occurs before 30 days or at Day 30
Satisfaction by the System Usability Scale
Measured: 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
Measured: At day 30
Visual Analogue Scale
Measure the pain in the scale from 0 to 10
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start3 Apr 2023
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Santelys Association, ENGIE, Fondation Boulanger
- Responsible party
- Sponsor
- Investigators
- Guillaume Piessen, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406024
- Sponsor's protocol ID
- 2021_0215
- Other IDs
- 2021-A02644-37
- Acronym
- FAISA-CORPPS
- Status last verified
- Dec 2025
- First submitted
- 24 May 2022
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEASIBILITY STUDY on the Use of a DIGITAL PLATFORM for Physical and Psychosocial RECONDITION After Major Neoplastic Surgery
- ClinicalTrials.gov ID
- NCT05406024
- Acronym / sponsor ID
- FAISA-CORPPS / 2021_0215
- Conditions
- Esophageal Neoplasm, Laryngeal Neoplasms
- Keywords
- Cancer, Physical and psychosocial rehabilitation, Digital platform, Esophagectomy, Laryngectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Santelys Association, ENGIE, Fondation Boulanger
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized for surgical management of esophageal or laryngeal cancer in Lille University Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital platformThe 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. | Device | – |
Primary outcome
Acceptability rate
Time frame: At 1 year
Realization of the ratio between the number of inclusion proposals and the number of accepted inclusions.
11 secondary outcomes
Adherence to exercise intervention program: Number of login
Time frame: 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
Adherence to exercise intervention program: type of exercises completed
Time frame: 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
Satisfaction by the System Usability Scale
Time frame: Discharge from hospital if it occurs before 30 days or at Day 30
Classification de Clavien-Dindo
Time frame: At day 30
Visual Analogue Scale
Time frame: 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
Warwick-Edinburgh Mental Wellbeing Scales
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Piessen, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasm and Laryngeal Neoplasms, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability rate (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.