NCT04969874

Remote Orthophonic Follow-up on Patients with Chronic Swallowing Disorders

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deglutition

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-07-21
• Last updated: 2025-03-21

Locations

1 site across 1 country: France