Deglutition Clinical Trial
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
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03705936 -
Metaplasticity in Human Pharyngeal Motor Cortex
|
N/A | |
| Completed |
NCT00475943 -
Movement of Epiglottis During Swallowing
|
N/A | |
| Terminated |
NCT03588806 -
Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills
|
Phase 4 | |
| Not yet recruiting |
NCT05452135 -
Cognitive - Motor Dual Task and Swallowing
|
||
| Not yet recruiting |
NCT03390972 -
Dexmedetomidine and Swallowing Function
|
Phase 4 | |
| Completed |
NCT04114617 -
Physiological Flow of Liquids in Healthy Swallowing
|