Remote Orthophonic Follow-up on Patients With Chronic Swallowing Disorders (E-CRIL_MAX)
Primary Purpose
Deglutition
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Remote follow-up
Sponsored by
About this trial
This is an interventional supportive care trial for Deglutition focused on measuring remote video follow-up, speech therapy, Aerodigestive cancer
Eligibility Criteria
Inclusion Criteria:
- Patient aged 18 or over and treated for cancer of the upper aero-digestive tract:
- Patient having spent a stay at the intensive rehabilitation center for laryngectomees
- Patient with a medical diagnosis of swallowing disorders at risk of inhalation
- Patient having the possibility of accessing a device allowing the use of the software by video (smartphone, tablet and / or computer)
- Informed consent signed by the patient.
- Patient affiliated to a social security scheme or equivalent
Exclusion Criteria:
- Progressive neurological disease leading to cognitive disorders
- Patient with guardianship, curators or legal protection
- Inability to give consent
- Patient participating in another research including an exclusion period still in progress
- Patient with speech therapy whose frequency is greater than 1 weekly session
Sites / Locations
- CHU Toulouse
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
remote follow-up
Arm Description
patients with chronic disorders on sequelae of anti-cancer treatments after an intensive rehabilitation stay will undergo 5 months of remote follow-up with speech therapists including questionnaires and interview
Outcomes
Primary Outcome Measures
patient attendance at monthly remote monitoring
Attendance will be evaluated by measuring the rate of patients who participated in at least 3 webvisions out of 5 and at the final visit in face-to-face consultation, compared to the number of patients included.
Secondary Outcome Measures
felt swallowing
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
felt swallowing
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
felt swallowing
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
felt swallowing
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
felt swallowing
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
felt swallowing
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
felt swallowing
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
Full Information
NCT ID
NCT04969874
First Posted
July 8, 2021
Last Updated
July 10, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Ligue contre le cancer, France
1. Study Identification
Unique Protocol Identification Number
NCT04969874
Brief Title
Remote Orthophonic Follow-up on Patients With Chronic Swallowing Disorders
Acronym
E-CRIL_MAX
Official Title
Feasibility of at Home Remote Monitoring Following a Stay in Intensive Rehabilitation in Patients With Chronic Swallowing Disorders Caused by Treatment for Cancer of the Aero-digestive Tract: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Ligue contre le cancer, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will assess the feasibility of monthly post rehabilitation remote monitoring, using the "MAX Educ" webvision app, in patients with sequelae of aerodigestive cancer treatments.
Detailed Description
The patients included in the study will benefit from a monthly video follow-up via the WEB tool "MAX Educ" during the first 6 months of their discharge from the rehabilitation center. They will be contacted each month during 5 months by the CRIL speech therapist for an interview (20 to 30 minutes).
The interview will take place in 2 stages; at first, a discussion phase, during which the speech therapist will take simple news of the patient. The second phase, more formal, will be the opportunity to collect the data necessary for the validation of the secondary endpoints. To do this, the speech therapist will use the Deglutition Handicap Index (DHI) and an interview grid.
The interview will be conducted using an interview sheet previously written by the project team. The following elements will be discussed: the perceived swallowing handicap (DHI), the instructions related to diet and their daily application, ongoing rehabilitation follow-ups, notable events as well as his psycho-emotional experience in relation to said disorders.
After signing the consent and verifying the eligibility criteria, all patients will be assessed upon discharge from the rehabilitation center by means of video swallowing fluoroscopy, allowing the deglutition score to be established.
EORTC Quality of Life Questionnaire (QLQ) QLQ-30 and its annex H & N35 and the DHI will also be completed at the inclusion visit at T0.
They will then be monitored monthly by video from Month 1 to Month 5.
During the end of research visit at 6 months, all the patients included will be reviewed in follow-up consultation with a doctor and a speech therapist within the intensive rehabilitation center for laryngectomees (which corresponds to the standard follow-up) and evaluated by video swallowing fluoroscopy. EORTC QLQ-30, EORTC QLQ-H & N35 quality of life questionnaires and the DHI will also have to be completed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition
Keywords
remote video follow-up, speech therapy, Aerodigestive cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Monocentric prospective longitudinal pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
remote follow-up
Arm Type
Other
Arm Description
patients with chronic disorders on sequelae of anti-cancer treatments after an intensive rehabilitation stay will undergo 5 months of remote follow-up with speech therapists including questionnaires and interview
Intervention Type
Other
Intervention Name(s)
Remote follow-up
Intervention Description
The feeling of swallowing will be assessed at the end of the stay at the rehabilitation center, which corresponds to the first visit, and then every month for 5 months during remote interviews and on discharge with the Deglutition Handicap Index (DHI), a self-assessment questionnaire for the swallowing handicap.
The quality of life will be assessed at the firs visit and 6 months after using the EORTC QLQ 30 quality of life scale and the H&N annex, a self-assessment questionnaire on the quality of life for people with cancer of the head and neck.
The satisfaction of users and the interest of city health professionals in the use of the "MAX Educ" tool as part of a monthly monitoring will be collected via the TUQ questionnaire, through the MAX platform at Month 6.
Primary Outcome Measure Information:
Title
patient attendance at monthly remote monitoring
Description
Attendance will be evaluated by measuring the rate of patients who participated in at least 3 webvisions out of 5 and at the final visit in face-to-face consultation, compared to the number of patients included.
Time Frame
Month 6 : end of follow-up
Secondary Outcome Measure Information:
Title
felt swallowing
Description
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
Time Frame
Month 0 : before follow-up
Title
felt swallowing
Description
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
Time Frame
Month 1 of follow-up
Title
felt swallowing
Description
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
Time Frame
Month 2 of follow-up
Title
felt swallowing
Description
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
Time Frame
Month 3 of follow-up
Title
felt swallowing
Description
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
Time Frame
Month 4 of follow-up
Title
felt swallowing
Description
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
Time Frame
Month 5 of follow-up
Title
felt swallowing
Description
The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow
Time Frame
Month 6 of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 18 or over and treated for cancer of the upper aero-digestive tract:
Patient having spent a stay at the intensive rehabilitation center for laryngectomees
Patient with a medical diagnosis of swallowing disorders at risk of inhalation
Patient having the possibility of accessing a device allowing the use of the software by video (smartphone, tablet and / or computer)
Informed consent signed by the patient.
Patient affiliated to a social security scheme or equivalent
Exclusion Criteria:
Progressive neurological disease leading to cognitive disorders
Patient with guardianship, curators or legal protection
Inability to give consent
Patient participating in another research including an exclusion period still in progress
Patient with speech therapy whose frequency is greater than 1 weekly session
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anais Galtier
Phone
05 67 77 18 01
Email
galtier.a@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anais Galtier
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anais GALTIER
Phone
05 67 77 18 01
Email
Galtier.a@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Clémence DEVOUCOUX
Phone
05 67 77 14 61
Email
Devoucoux.c@chu-toulouse.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Orthophonic Follow-up on Patients With Chronic Swallowing Disorders
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