NCT05406024

Brief 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...).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2024

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

May 24, 2022

Last Update Submit

December 4, 2025

Conditions

Esophageal NeoplasmLaryngeal Neoplasms

Keywords

CancerPhysical and psychosocial rehabilitationDigital platformEsophagectomyLaryngectomy

Outcome Measures

Primary Outcomes (1)

  • Acceptability rate

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

    At 1 year

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universtaire

Lille, 59037, France

Location

MeSH Terms

Conditions

Esophageal NeoplasmsLaryngeal NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesOtorhinolaryngologic NeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Study Officials

  • Guillaume Piessen, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

June 6, 2022

Study Start

April 3, 2023

Primary Completion

April 19, 2024

Study Completion

April 19, 2024

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations

FR(1)