Swallowing DisordersE-CRILNCT04859595

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

A study testing Telephone follow-up in people with Swallowing Disorders, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Swallowing Disorders
What is being tested?: Telephone follow-up
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteFrance
Study dates: 29 Jul 2021to 1 May 2023
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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

CHU Toulouse
Toulouse

Other trials in France

About this study

Official title: 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

Read the 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.

Conditions: Swallowing Disorders
Being tested: Telephone follow-up
Keywords: cancer of the upper aerodigestive tract, chronic swallowing disorders sequelae
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telephone follow-upOther
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.

Study groups in NCT04859595
Study group	Role	What they receive
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). Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 20211 May 2023

First posted26 Apr 2021
Study start29 Jul 2021
Primary completion1 May 2023
Study completion1 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Swallowing DisordersStudies 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: Randomised
Intervention model: Parallel groups
Model description: Single-center, open-label, prospective study
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04859595
Sponsor's protocol ID: RC31/21/0022
Acronym: E-CRIL
Status last verified: Aug 2023
First submitted: 19 Apr 2021
Last updated: 23 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Swallowing Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04859595
Acronym / sponsor ID: E-CRIL / RC31/21/0022
Conditions: Swallowing Disorders
Keywords: cancer of the upper aerodigestive tract, chronic swallowing disorders sequelae
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University Hospital, ToulouseUniversity, hospital or other
Collaborators: Fondation de l'Avenir
Study start: 29 Jul 2021 (actual)
Primary completion: 1 May 2023 (actual)
Study completion: 1 May 2023 (actual)
First posted: 26 Apr 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.

Detailed description

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.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Single-center, open-label, prospective study

Arm	Type	Receives
telephone follow-up arm	Experimental	Other: Telephone follow-upThe 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).
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.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

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
Telephone follow-upMonthly 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.	Other	telephone follow-up arm

Primary outcome

Maintenance of functional capacities
Time frame: Baseline T0 : At the end of the initial routine reeducation intervention
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
Maintenance of functional capacities
Time frame: T1M : 1 month after Baseline T0 (the end of the routine reeducation intervention)
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
Maintenance of functional capacities
Time frame: T2M : 2 months after Baseline T0 (the end of the routine reeducation intervention)
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
Maintenance of functional capacities
Time frame: T3M : 3 months after Baseline T0 the end of the routine reeducation intervention
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
Maintenance of functional capacities
Time frame: T4M : 4 months after Baseline T0 the end of the routine reeducation intervention
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
Maintenance of functional capacities
Time frame: T5M : 5 months after Baseline T0 the end of the routine reeducation intervention
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
Maintenance of functional capacities
Time frame: T6M : 6 months after BaselineT0 the end of the routine reeducation intervention
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.

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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 Telephone follow-up in people with Swallowing Disorders, 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 6 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: finished, as of the sponsor's last update on 23 Aug 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maintenance of functional capacities (time frame: Baseline T0 : At the end of the initial routine reeducation intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04859595.

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 23 Aug 2023.