At-home Monitoring of Patients During Chemoradiation for Oesophageal CanceR: the AMCOR Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine the feasibility of at home monitoring in addition to standard of care
研究概览
简要总结
Chemoradiotherapy is part of standard treatment for patients with locally advanced oesophageal cancer. Some patients with oesophageal cancer treated with chemoradiotherapy do not complete treatment due to toxicity, or face complications after treatment. Therefore, there is a need for better tools for assessing patients' fitness for chemoradiotherapy and to pick up early signals of deteriorating overall physical condition and complications during and after treatment to timely implement supportive care measures. Tools enabling monitoring physical activity, vital parameters and creatinine concentration in the blood at home are available but have not yet been implemented in patients undergoing chemoradiotherapy for oesophageal cancer. The feasibility and added value remain unknown.
详细描述
This is an observational feasibility study in which 30 ambulant patients with oesophageal cancer are continuously monitored from 1 week before chemoradiation until 3 weeks after chemoradiation for oesophageal cancer in addition to standard care.
We provide them with a monitoring kit of Siemens and a finger prick test of Nova Biomedical.
The monitoring kit of Siemens Healthineers contains multiple measuring tools, including:
- a blood pressure measuring device, which will be applied to the upper arm.
- an oxygen saturation measuring device, which will also measure the pulse when applied to the fingertip.
- a scale which will measure body weight.
- a skin thermometer which will detect body temperature.
- An activity tracker/watch which will measure every step taken during the day when worn around the wrist by the participant. All measurements will be automatically send to the online portal, which can be seen by the investigators.
Participants will receive a dedicated smartphone with an application to monitor their measurements at home for the duration of their study participation. The telephone does not provide any other functions than the specific app function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 at the time of signing informed consent.
- •Histologically proven adenocarcinoma, squamous cell carcinoma or mixed type of the oesophagus or gastro-oesophageal junction.
- •Indication for definitive or neoadjuvant CRT, with chemotherapy that consists of weekly carboplatin/paclitaxel.
- •Written, informed consent.
- •Ability to comply with all protocol required actions (at home measurements are done individually by the participant him- or herself).
排除标准
- •Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or the carrying out of the measurements at home.
结局指标
主要结局
Determine the feasibility of at home monitoring in addition to standard of care
时间窗: From one week before the start of treatment until three weeks after the end of treatment
To determine the feasibility of at home monitoring in addition to standard care of patients with oesophageal cancer during chemoradiotherapy. Feasible is defined as ≥80% of measurements completed in ≥80% of the patients.
次要结局
- Determine the number of extra telephone contacts(From one week before the start of treatment until three weeks after the end of treatment)
- Assess taste changes from baseline with the use of Chemotherapy-induced Taste Alteration Scale (CiTAS) questionnaire(From one week before the start of treatment until three weeks after the end of treatment)
- Determine completion rates(From one week before the start of treatment until three weeks after the end of treatment)
- Determine the number of extra hospital visits(From one week before the start of treatment until three weeks after the end of treatment)
- Determine radiotherapy and chemotherapy completion rates(From one week before the start of treatment until three weeks after the end of treatment)
- Assess changes in quality of life from baseline in the remaining symptoms and domains of the EORTC QLQ-C30 and the oesophageal cancer specific EORTC QLQ-OES18.(From one week before the start of treatment until three weeks after the end of treatment)
- Assess changes in quality of life from baseline in the domains overall health/QoL score, dysphagia and fatigue of the validated EORTC QLQ-C30 and QLQ-OES18.(From one week before the start of treatment until three weeks after the end of treatment)