Remote Orthophonic Follow-up on Patients with Chronic Swallowing Disorders
NCT ID: NCT04969874
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-12-31
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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remote follow-up
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
Remote follow-up
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.
Interventions
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Remote follow-up
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Ligue contre le cancer, France
OTHER
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Anais Galtier
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC31/21/0023
Identifier Type: -
Identifier Source: org_study_id
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