Follow-up After a Stay in Intensive Rehabilitation for Patients With Swallowing Disorders (NCT04859595) | Clinical Trial Compass
CompletedNot Applicable
Follow-up After a Stay in Intensive Rehabilitation for Patients With Swallowing Disorders
France35 participantsStarted 2021-07-29
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maintenance of functional capacities
Timeframe: Baseline T0 : At the end of the initial routine reeducation intervention
2
Maintenance of functional capacities
Timeframe: T1M : 1 month after Baseline T0 (the end of the routine reeducation intervention)
3
Maintenance of functional capacities
Timeframe: T2M : 2 months after Baseline T0 (the end of the routine reeducation intervention)
4
Maintenance of functional capacities
Timeframe: T3M : 3 months after Baseline T0 the end of the routine reeducation intervention
5
Maintenance of functional capacities
Timeframe: T4M : 4 months after Baseline T0 the end of the routine reeducation intervention
6
Maintenance of functional capacities
Timeframe: T5M : 5 months after Baseline T0 the end of the routine reeducation intervention