ClinicalTrials.gg
WithdrawnNCT04969874E-CRIL_MAXUpdated May 12, 2026

Remote Orthophonic Follow-up on Patients With Chronic Swallowing Disorders

An interventional study of Remote follow-up in Deglutition, sponsored by University Hospital, Toulouse. Withdrawn at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Software problem

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2021, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

The patients included in the study will benefit from a monthly video follow-up via the WEB tool "MAX Educ" during the first 6 months of their discharge from the rehabilitation center. They will be contacted each month during 5 months by the CRIL speech therapist for an interview (20 to 30 minutes).

The interview will take place in 2 stages; at first, a discussion phase, during which the speech therapist will take simple news of the patient. The second phase, more formal, will be the opportunity to collect the data necessary for the validation of the secondary endpoints. To do this, the speech therapist will use the Deglutition Handicap Index (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 perceived swallowing handicap (DHI), the instructions related to diet and their daily application, ongoing rehabilitation follow-ups, notable events as well as his psycho-emotional experience in relation to said disorders.

After signing the consent and verifying the eligibility criteria, all patients will be assessed upon discharge from the rehabilitation center by means of video swallowing fluoroscopy, allowing the deglutition score to be established.

EORTC Quality of Life Questionnaire (QLQ) QLQ-30 and its annex H \& N35 and the DHI will also be completed at the inclusion visit at T0.

They will then be monitored monthly by video from Month 1 to Month 5.

During the end of research visit at 6 months, all the patients included will be reviewed in follow-up consultation with a doctor and a speech therapist within the intensive rehabilitation center for laryngectomees (which corresponds to the standard follow-up) and evaluated by video swallowing fluoroscopy. EORTC QLQ-30, EORTC QLQ-H \& N35 quality of life questionnaires and the DHI will also have to be completed.

02

Conditions studied

  • Deglutition

Keywords

  • remote video follow-up
  • speech therapy
  • Aerodigestive cancer
03

In context

Communication Disorders

149 studies on the registry are indexed under Communication Disorders; 44 are open to participants now.

Browse Communication Disorders studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)
  • signed by the patient.
  • Patient affiliated to a social security scheme or equivalent

Exclusion criteria

Exclusion Criteria:

  • Progressive neurological disease leading to cognitive disorders
  • Patient with guardianship, curators or legal protection
  • Inability to give consent
  • Patient participating in another research including an exclusion period still in progress
  • Patient with speech therapy whose frequency is greater than 1 weekly session
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    remote follow-up

    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

  • OtherRemote follow-up

    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.

06

What researchers measure

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.

    Time frame: Month 6 : end of follow-up

Secondary outcomes

  1. felt swallowing

    The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow

    Time frame: Month 0 : before follow-up

  2. felt swallowing

    The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow

    Time frame: Month 1 of follow-up

  3. felt swallowing

    The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow

    Time frame: Month 2 of follow-up

  4. felt swallowing

    The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow

    Time frame: Month 3 of follow-up

  5. felt swallowing

    The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow

    Time frame: Month 4 of follow-up

  6. felt swallowing

    The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow

    Time frame: Month 5 of follow-up

  7. felt swallowing

    The feeling of swallowing will be evaluated with the Deglutition Handicap Index (DHI), a swallowing handicap self-assessment questionnaire. ranking from 30 to 150, 30 corresponding to no handicap swallowing, and 150 being the worst handicap to swallow

    Time frame: Month 6 of follow-up

07

Study locations

1 site
  • CHU Toulouse
    Toulouse, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04969874
Collaborators
Ligue contre le cancer, France
Responsible party
Sponsor
First posted
Jul 21, 2021
Start date
Jan 1, 2021
Primary completion
May 7, 2026 (estimated)
Completion
May 7, 2026
Last update
May 12, 2026

Study contacts

Anais Galtier
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion