Follow-up After a Stay in Intensive Rehabilitation for Patients With Swallowing Disorders (E-CRIL)

Toulouse University Hospital

Status: Completed

Conditions: Swallowing Disorders

Treatments: Other: Telephone follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT04859595

RC31/21/0022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 2 patient groups

telephone follow-up arm

Experimental group

Description:

The experimental arm corresponds to the patient benefiting from a monthly telephone follow-up during the first 6 months of their discharge from the reeducation center : "CRIL" (from M1 to M6). They will be contacted each month by CRIL's speech therapist for a telephone interview (20 to 30 minutes).

Treatment:

Other: Telephone follow-up

control arm

No Intervention group

Description:

The comparison group will follow the standard follow-up protocol. A technician will contact the patients in the control arm to obtain the TIMES score each month. No further telephone follow-up will be carried out.