DeglutitionE-CRIL_MAXNCT04969874
Remote Orthophonic Follow-up on Patients With Chronic Swallowing Disorders
A study testing Remote follow-up in people with Deglutition, run by University Hospital, Toulouse at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Deglutition
- What is being tested?
- Remote follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 7 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of at Home Remote Monitoring Following a Stay in Intensive Rehabilitation in Patients With Chronic Swallowing Disorders Caused by Treatment for Cancer of the Aero-digestive Tract: Pilot Study
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.
- Conditions
- Deglutition
- Being tested
- Remote follow-up
- Keywords
- remote video follow-up, speech therapy, Aerodigestive cancer
- Medical subject headings
- Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote follow-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Remote follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6 : end of follow-up
Secondary outcomes (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
Measured: Month 0 : before follow-up
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
Measured: Month 1 of follow-up
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
Measured: Month 2 of follow-up
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
Measured: Month 3 of follow-up
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
Measured: Month 4 of follow-up
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
Measured: Month 5 of follow-up
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
Measured: Month 6 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jan 2021
- Primary completion7 May 2026 (estimated)
- Study completion7 May 2026
Why it stopped: Software problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeglutitionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric prospective longitudinal pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Anais Galtier, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969874
- Sponsor's protocol ID
- RC31/21/0023
- Acronym
- E-CRIL_MAX
- Status last verified
- May 2026
- First submitted
- 8 Jul 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of at Home Remote Monitoring Following a Stay in Intensive Rehabilitation in Patients With Chronic Swallowing Disorders Caused by Treatment for Cancer of the Aero-digestive Tract: Pilot Study
- ClinicalTrials.gov ID
- NCT04969874
- Acronym / sponsor ID
- E-CRIL_MAX / RC31/21/0023
- Conditions
- Deglutition
- Keywords
- remote video follow-up, speech therapy, Aerodigestive cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Software problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 7 May 2026 (estimated)
- Study completion
- 7 May 2026 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric prospective longitudinal pilot study
| Arm | Type | Receives |
|---|---|---|
| remote follow-up | Other | Other: Remote follow-uppatients 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote follow-upThe 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. | Other | remote follow-up |
Primary outcome
patient attendance at monthly remote monitoring
Time frame: Month 6 : end of follow-up
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.
7 secondary outcomes
felt swallowing
Time frame: Month 0 : before follow-up
felt swallowing
Time frame: Month 1 of follow-up
felt swallowing
Time frame: Month 2 of follow-up
felt swallowing
Time frame: Month 3 of follow-up
felt swallowing
Time frame: Month 4 of follow-up
felt swallowing
Time frame: Month 5 of follow-up
felt swallowing
Time frame: Month 6 of follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Early Feeding TL Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anais Galtier principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote follow-up in people with Deglutition, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient attendance at monthly remote monitoring (time frame: Month 6 : end of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.