Follow-up After a Stay in Intensive Rehabilitation for Patients With Swallowing Disorders
Condition: Swallowing Disorders
MeSH terms: Deglutition Disorders
Study type: Interventional

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.
    

Intervention name(s): Telephone follow-up
Intervention type(s): Other
Intervention description(s): Monthly follow-up by telephone from M1 to M6. The interview will unroll in 2 stages, a first stage of discussion during which the speech therapist will take news of the patient. The second, more formal phase will be the opportunity to collect the data necessary for the validation of the primary and secondary outcomes. To do this, the speech therapist will use the Functional Oral Intake Scale (FOIS) score, the 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 description of oral food intakes (TIMES), the perceived swallowing handicap (DHI), the instructions related to the diet and their daily application, ongoing rehabilitation follow-ups, notable events as well, then his emotional and psychological experience in relation to the disorder.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, open-label, prospective study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cancer of the upper aerodigestive tract; chronic swallowing disorders sequelae