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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
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04969874
Acronym
E-CRIL_MAX
Enrollment
0
Registered
2021-07-21
Start date
2021-01-01
Completion date
2026-05-07
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition

Keywords

remote video follow-up, speech therapy, Aerodigestive cancer

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.

Interventions

OTHERRemote 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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER
Ligue contre le cancer, France
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Monocentric prospective longitudinal pilot study

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
patient attendance at monthly remote monitoringMonth 6 : end of follow-upAttendance 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

MeasureTime frameDescription
felt swallowingMonth 0 : before follow-upThe 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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAnais Galtier

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026