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

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

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.

Study Overview

• Status: Completed
• Conditions: Swallowing Disorders
• Intervention / Treatment: Other: Telephone 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Chu Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telephone follow-up arm; 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).	Other: Telephone follow-up; 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.
No Intervention: control arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of functional capacities	Assessed by establishing the FOIS (Functional Oral Intake Scale) score : Level from 1 to 7, (1 being the worse functional oral intake, 7 being the best functional oral intake possible) TUBE DEPENDENT (levels 1-3); No oral intake; Tube dependent with minimal/inconsistent oral intake; Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7); Total oral intake of a single consistency; Total oral intake of multiple consistencies requiring special preparation; Total oral intake with no special preparation, but must avoid specific foods or liquid items; Total oral intake with no restrictions	Baseline T0 : At the end of the initial routine reeducation intervention
Maintenance of functional capacities	Assessed by establishing the FOIS (Functional Oral Intake Scale) score : Level from 1 to 7 : TUBE DEPENDENT (levels 1-3); No oral intake; Tube dependent with minimal/inconsistent oral intake; Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7); Total oral intake of a single consistency; Total oral intake of multiple consistencies requiring special preparation; Total oral intake with no special preparation, but must avoid specific foods or liquid items; Total oral intake with no restrictions	T1M : 1 month after Baseline T0 (the end of the routine reeducation intervention)
Maintenance of functional capacities	Assessed by establishing the FOIS (Functional Oral Intake Scale) score : Level from 1 to 7 : TUBE DEPENDENT (levels 1-3); No oral intake; Tube dependent with minimal/inconsistent oral intake; Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7); Total oral intake of a single consistency; Total oral intake of multiple consistencies requiring special preparation; Total oral intake with no special preparation, but must avoid specific foods or liquid items; Total oral intake with no restrictions	T2M : 2 months after Baseline T0 (the end of the routine reeducation intervention)
Maintenance of functional capacities	Assessed by establishing the FOIS (Functional Oral Intake Scale) score : Level from 1 to 7 : TUBE DEPENDENT (levels 1-3); No oral intake; Tube dependent with minimal/inconsistent oral intake; Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7); Total oral intake of a single consistency; Total oral intake of multiple consistencies requiring special preparation; Total oral intake with no special preparation, but must avoid specific foods or liquid items; Total oral intake with no restrictions	T3M : 3 months after Baseline T0 the end of the routine reeducation intervention
Maintenance of functional capacities	Assessed by establishing the FOIS (Functional Oral Intake Scale) score : Level from 1 to 7 : TUBE DEPENDENT (levels 1-3); No oral intake; Tube dependent with minimal/inconsistent oral intake; Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7); Total oral intake of a single consistency; Total oral intake of multiple consistencies requiring special preparation; Total oral intake with no special preparation, but must avoid specific foods or liquid items; Total oral intake with no restrictions	T4M : 4 months after Baseline T0 the end of the routine reeducation intervention
Maintenance of functional capacities	Assessed by establishing the FOIS (Functional Oral Intake Scale) score : Level from 1 to 7 : TUBE DEPENDENT (levels 1-3); No oral intake; Tube dependent with minimal/inconsistent oral intake; Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7); Total oral intake of a single consistency; Total oral intake of multiple consistencies requiring special preparation; Total oral intake with no special preparation, but must avoid specific foods or liquid items; Total oral intake with no restrictions	T5M : 5 months after Baseline T0 the end of the routine reeducation intervention
Maintenance of functional capacities	Assessed by establishing the FOIS (Functional Oral Intake Scale) score: Level from 1 to 7 : TUBE DEPENDENT (levels 1-3); No oral intake; Tube dependent with minimal/inconsistent oral intake; Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7); Total oral intake of a single consistency; Total oral intake of multiple consistencies requiring special preparation; Total oral intake with no special preparation, but must avoid specific foods or liquid items; Total oral intake with no restrictions	T6M : 6 months after BaselineT0 the end of the routine reeducation intervention

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Fondation de l'Avenir
• Investigators: Principal Investigator: Anais Galtier, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cancer of the upper aerodigestive tract; chronic swallowing disorders sequelae
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: RC31/21/0022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No