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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- patient attendance at monthly remote monitoring
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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
排除标准
- •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
研究组 & 干预措施
remote follow-up
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
干预措施: Remote follow-up (Other)
结局指标
主要结局
patient attendance at monthly remote monitoring
时间窗: 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.
次要结局
- felt swallowing(Month 6 of follow-up)