App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change in rates of weight loss with additional app-based Patient Care
研究概览
简要总结
Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.
详细描述
Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.
Patients in the experimental arm receive the daily reminder message via app (Emento) that they should pay attention to adequate caloric intake. In addition, these patients receive 3 screening questions about their current health and nutritional status twice a week.
In case of relevant deterioration (any negative value in the screening questions is explained under study procedure), additional further questions are asked, which are specifically aimed at the side effects of the tumor therapy (mainly dysphagia, pain). The answers will be transmitted to the radiation clinic.
If a question is answered positively, this is reported to the radiotherapy clinic on the one hand and on the other hand, the patient is asked to consult the doctor in the clinic as soon as possible.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with squamous cell carcinoma in the head and neck region, who receive a postsurgical or definitive radio(chemo)therapy
- •Patients who have a smartphone on which the Emento app can be installed
- •Minimum age 18 years
排除标准
- •Patients who are represented by a legal guardian
- •Patients who are not suitable for participation in the study due to a language barrier
研究组 & 干预措施
App Usage
Patients receive the daily reminder message via app (Emento) that they should pay attention to sufficient calorie intake. In addition, these patients receive 3 screening questions about their current health and nutritional status twice a week.
干预措施: App Usage (Procedure)
Standard
Patients in the control arm receive supportive care during and after radio(chemo)therapy according to hospital standards.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in rates of weight loss with additional app-based Patient Care
时间窗: during trial, about 24 months
次要结局
- Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy.(during trial, about 24 months)
- Rate of therapy interruptions/discontinuations(during trial, about 24 months)
- Overall survival(during trial, about 24 months)
- Disease-free/progression-free survival(during trial, about 24 months)
- Change of Loco-regional tumor control(during trial, about 24 months)
- Frequency of additional app-triggered contacts of the clinic with the patients(during trial, about 24 months)
- Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy.(during trial, about 24 months)
- Frequency of deteriorations in health status subjectively reported by patients and recorded via the app.(during trial, about 24 months)
- Frequency of critical health conditions (physician-verified) detected earlier by the app.(during trial, about 24 months)
- Change in quality of life measured per questionnaires(during trial, about 24 months)