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| Name | Class |
|---|---|
| Fondation de l'Avenir | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone follow-up | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| 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)
| 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)
| T2M : 2 months after Baseline T0 (the end of the routine reeducation intervention) |
| Maintenance of functional capacities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anais Galtier | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Toulouse | Toulouse | France |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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Single-center, open-label, prospective study
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Assessed by establishing the FOIS (Functional Oral Intake Scale) score : Level from 1 to 7 : TUBE DEPENDENT (levels 1-3)
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| 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)
| 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)
| 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)
| T6M : 6 months after BaselineT0 the end of the routine reeducation intervention |
| D010038 | Otorhinolaryngologic Diseases |