Clinical trial NCT04859595: Follow-up After a Stay in Intensive Rehabilitation for Patients With Swallowing Disorders
Official title: Benefit of an at Home Telephone Follow-up After a Stay in an Intensive Rehabilitation Center for Patients With Chronic Swallowing Disorders Following a Upper Aero-digestive Tract Cancer Treatment : Open, Controlled, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Swallowing Disorders
Keywords: cancer of the upper aerodigestive tract
chronic swallowing disorders sequelae
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2021-04-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, open-label, prospective study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective, open-label, randomized, single-center study evaluating the benefit of a months long monthly telephone follow-up for patients with chronic disorders following the after-effects of anti-cancer treatments after an intensive rehabilitation stay versus standard follow-up.

Detailed description: Upper aerodigestive tract (UAT) cancer is a malignant tumor in the hypopharynx, larynx, oropharynx and oral cavity. In 2017, 15,000 new cases of cancers of the upper aero-digestive tract were identified: which in France places them among the most frequent cancers.

The treatments used to treat UAT cancers are of three types: surgery, radiotherapy and radio chemotherapy and can have significant functional consequences, in particular on swallowing and phonation.

This therapeutic management is routinely associated with supportive care, in order to ensure the functional rehabilitation that will allow the maintenance of the quality of life of these patients as well as their entourage by reducing the side effects of the treatments and the effects of disease.

Intensive rehabilitation is offered to patients who have been treated for UAT cancer in order to speed up the learning of new behaviors and improve their memorization. Thus, these patients benefit from intensive multidisciplinary rehabilitation within the Intensive Reeducation Center for Laryngectomees.

However, it is not uncommon to see patients return for a second stay following a loss of the benefits learned, in particular on the swallowing function, omissions of food safety instructions or an interruption of local rehabilitation.

Studies have shown that remote monitoring can have a positive impact on the health of these patients. However, no study has assessed the impact of such monitoring on functional swallowing abilities.

This study will asses the impact of a monthly phone call during 6 months on patients with chronic swallowing disorders compared to the routine follow up. The telephone interviews will mainly consist of questionnaires.

Eligibility criteria: Inclusion Criteria:

* Patients treated for cancer of the upper aero-digestive tract
* Patients who have stayed at the intensive laryngectomee rehabilitation center CRIL
* Patients with a medical diagnosis of swallowing disorders at risk of inhalation (i.e. a Penetration Aspiration Scale score ≥5)
* Informed consent signed by the patient.
* Patients with social security or equivalent
* Patient who does not need intensive speech therapy when leaving the rehabilitation center or only benefits from one rehabilitation session per week

Exclusion Criteria:

* Progressive neurological disease leading to cognitive disorders (MOntreal Cognitive Assessment ≤ 17)
* Patient under guardianship, curator or legal protection
* Inability to provide the person with enlightened information and to ensure the subject's compliance due to impaired physical and / or psychological health,
* Patient who cannot be reached by telephone or does not have a telephone line
* Patient participating in another research including an exclusion period still in progress
* Patient whose state of health on leaving the rehabilitation center requires intensive town speech therapy for more than 1 rehabilitation session per week

Primary outcomes:
measure: Maintenance of functional capacities
timeFrame: Baseline T0 : At the end of the initial routine reeducation intervention
measure: Maintenance of functional capacities
timeFrame: T1M : 1 month after Baseline T0 (the end of the routine reeducation intervention)
measure: Maintenance of functional capacities
timeFrame: T2M : 2 months after Baseline T0 (the end of the routine reeducation intervention)
measure: Maintenance of functional capacities
timeFrame: T3M : 3 months after Baseline T0 the end of the routine reeducation intervention
measure: Maintenance of functional capacities
timeFrame: T4M : 4 months after Baseline T0 the end of the routine reeducation intervention
measure: Maintenance of functional capacities
timeFrame: T5M : 5 months after Baseline T0 the end of the routine reeducation intervention
measure: Maintenance of functional capacities
timeFrame: T6M : 6 months after BaselineT0 the end of the routine reeducation intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Anais Galtier
role: PRINCIPAL_INVESTIGATOR
References: