Follow-up After a Stay in Intensive Rehabilitation for Patients With Swallowing Disorders

NCT04859595 | Completed

• 1 other identifier: RC31/21/0022
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Swallowing Disorders

Keywords

cancer of the upper aerodigestive tract; chronic swallowing disorders sequelae

Outcome Measures

Primary Outcomes (7)

• 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) 1. No oral intake 2. Tube dependent with minimal/inconsistent oral intake 3. Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7) 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. 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) 1. No oral intake 2. Tube dependent with minimal/inconsistent oral intake 3. Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7) 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. 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) 1. No oral intake 2. Tube dependent with minimal/inconsistent oral intake 3. Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7) 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. 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) 1. No oral intake 2. Tube dependent with minimal/inconsistent oral intake 3. Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7) 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. 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) 1. No oral intake 2. Tube dependent with minimal/inconsistent oral intake 3. Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7) 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. 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) 1. No oral intake 2. Tube dependent with minimal/inconsistent oral intake 3. Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7) 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. 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) 1. No oral intake 2. Tube dependent with minimal/inconsistent oral intake 3. Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7) 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. Total oral intake with no restrictions

  T6M : 6 months after BaselineT0 the end of the routine reeducation intervention

Study Arms (2)

telephone follow-up arm

EXPERIMENTAL

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

control arm

NO INTERVENTION

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.

Interventions

Telephone follow-up OTHER

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.

telephone follow-up arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 whose state of health on leaving the rehabilitation center requires intensive town speech therapy for more than 1 rehabilitation session per week

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Anais Galtier

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, open-label, prospective study

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 26, 2021
• Study Start: July 29, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

FR (1)