Clinical trial NCT04969874: Remote Orthophonic Follow-up on Patients with Chronic Swallowing Disorders
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Deglutition
Keywords: remote video follow-up
speech therapy
Aerodigestive cancer
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2021-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric prospective longitudinal pilot study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: patient attendance at monthly remote monitoring
timeFrame: Month 6 : end of follow-up
Secondary outcomes:
measure: felt swallowing
timeFrame: Month 0 : before follow-up
measure: felt swallowing
timeFrame: Month 1 of follow-up
measure: felt swallowing
timeFrame: Month 2 of follow-up
measure: felt swallowing
timeFrame: Month 3 of follow-up
measure: felt swallowing
timeFrame: Month 4 of follow-up
measure: felt swallowing
timeFrame: Month 5 of follow-up
measure: felt swallowing
timeFrame: Month 6 of follow-up
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Anais Galtier
role: PRINCIPAL_INVESTIGATOR
References: