Remote Orthophonic Follow-up on Patients with Chronic Swallowing Disorders

NCT04969874 | Not Yet Recruiting

• 1 other identifier: RC31/21/0023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study will assess the feasibility of monthly post rehabilitation remote monitoring, using the "MAX Educ" webvision app, in patients with sequelae of aerodigestive cancer treatments.

Conditions

Deglutition

Keywords

remote video follow-up; speech therapy; Aerodigestive cancer

Outcome Measures

Primary Outcomes (1)

• patient attendance at monthly remote monitoring

  Attendance will be evaluated by measuring the rate of patients who participated in at least 3 webvisions out of 5 and at the final visit in face-to-face consultation, compared to the number of patients included.

  Month 6 : end of follow-up

Secondary Outcomes (7)

• felt swallowing

  Month 0 : before follow-up

• felt swallowing

  Month 1 of follow-up

• felt swallowing

  Month 2 of follow-up

• felt swallowing

  Month 3 of follow-up

• felt swallowing

  Month 4 of follow-up

Study Arms (1)

remote follow-up

OTHER

patients with chronic disorders on sequelae of anti-cancer treatments after an intensive rehabilitation stay will undergo 5 months of remote follow-up with speech therapists including questionnaires and interview

Other: Remote follow-up

Interventions

Remote follow-up OTHER

The feeling of swallowing will be assessed at the end of the stay at the rehabilitation center, which corresponds to the first visit, and then every month for 5 months during remote interviews and on discharge with the Deglutition Handicap Index (DHI), a self-assessment questionnaire for the swallowing handicap. The quality of life will be assessed at the firs visit and 6 months after using the EORTC QLQ 30 quality of life scale and the H\&N annex, a self-assessment questionnaire on the quality of life for people with cancer of the head and neck. The satisfaction of users and the interest of city health professionals in the use of the "MAX Educ" tool as part of a monthly monitoring will be collected via the TUQ questionnaire, through the MAX platform at Month 6.

remote follow-up

Eligibility Criteria

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

You may qualify if:

• Patient aged 18 or over and treated for cancer of the upper aero-digestive tract:
• Patient having spent a stay at the intensive rehabilitation center for laryngectomees
• Patient with a medical diagnosis of swallowing disorders at risk of inhalation
• Patient having the possibility of accessing a device allowing the use of the software by video (smartphone, tablet and / or computer)
• Informed consent signed by the patient.
• Patient affiliated to a social security scheme or equivalent

You may not qualify if:

• Progressive neurological disease leading to cognitive disorders
• Patient with guardianship, curators or legal protection
• Inability to give consent
• Patient with speech therapy whose frequency is greater than 1 weekly session

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Ligue contre le cancer, France: collaborator

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Communication Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Anais Galtier

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anais Galtier

CONTACT

05 67 77 18 01; galtier.a@chu-toulouse.fr

Study Design

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

Model Details: Monocentric prospective longitudinal pilot study

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 21, 2021
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)