Remote Orthophonic Follow-up on Patients with Chronic Swallowing Disorders (E-CRIL_MAX)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Deglutition

Treatments: Other: Remote follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT04969874

RC31/21/0023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

remote follow-up

Other group

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

Treatment:

Other: Remote follow-up