Feasibility Study CORPPS

Esophageal Neoplasm Clinical Trial

— FAISA-CORPPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05406024
• Other study ID #: 2021_0215
• Secondary ID: 2021-A02644-37
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: September 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Guillaume Piessen, MD,PhD
• Phone: 0320445962
• Email: guillaume.piessen[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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...).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasm
• Esophageal Neoplasms
• Laryngeal Neoplasms
• Neoplasms

Intervention

Device:
• Digital 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Lille	ENGIE, Fondation Boulanger, Santelys Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability rate	Realization of the ratio between the number of inclusion proposals and the number of accepted inclusions.	At 1 year
Secondary	Adherence to exercise intervention program: Number of login		Discharge from hospital if it occurs before 30 days or at Day 30
Secondary	Adherence to exercise intervention program: Number of exercises completed		Discharge from hospital if it occurs before 30 days or at Day 30
Secondary	Adherence to exercise intervention program: type of exercises completed		Discharge from hospital if it occurs before 30 days or at Day 30
Secondary	Adherence to exercise intervention program: retention rate		Discharge from hospital if it occurs before 30 days or at Day 30
Secondary	Satisfaction by the System Usability Scale		Discharge from hospital if it occurs before 30 days or at Day 30
Secondary	Classification de Clavien-Dindo	Evaluation of the incidence of postoperative complications based on the Clavien-Dindo classification grade II	At day 30
Secondary	Visual Analogue Scale	Measure the pain in the scale from 0 to 10	Before and after each activity
Secondary	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)	Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
Secondary	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.	Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
Secondary	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.	Baseline, Discharge from hospital if it occurs before 30 days and at Day 30
Secondary	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	Baseline, Discharge from hospital if it occurs before 30 days and at Day 30