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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Maintenance of functional capacities
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Maintenance of functional capacities
时间窗: 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
次要结局
未报告次要终点