Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Quality of life
研究概览
简要总结
The primary goal of the patient-led follow-up from home, is the improvement of quality of life and the reduction of stress in patients, while obtaining a more complete picture of their health status.
A series of assessments are performed in the home setting:
- Blood withdrawal for CEA determination
- Quality of life questionnaires to assess both mental and physical symptoms
- Vital parameters using a Smart Sensor
详细描述
Primary Objective: To further develop and evaluate a personalised patient-centred surveillance programme including a feedback platform for patients after curative treatment for CRC in terms of health-related quality of life (HRQoL) and significantly decrease the number of in-hospital appointments, by relocating the follow-up care to the home-setting. The goal is for this surveillance program to be non-inferior to standard of care follow-up at 36 months, in terms of quality of life. The quality of life in patients will be assessed with the EQ 5D-5L questionnaire and compared to median EQ-5D-5L scores for patients receiving standard of care follow-up. In current literature, the median HRQoL VAS score for patients after surgery for CRC is 62.05 points (1).
The second goal of the program is to relocate part of the in-hospital follow-up care to the home-setting. In standard of care follow-up, at 36 months patients would have had 10 in-hospital appointments. The effect of the PROMISE study on the number of in-hospital appointments, will be assessed at 36 months postoperatively.
The PROMISE study is a multi-centre prospective regional implementation study of a personalised patient-centred surveillance program including a feedback platform for patients after curative treatment for CRC.
All patients who underwent surgery with curative intent for non-metastatic CRC with scheduled postoperative surveillance are potentially eligible.
Follow-up in this study is performed according to the acting Dutch national guidelines. Current guidelines advocate CEA level measurements to be performed every 3-6 months for first 2 years after surgery and every 6-12 months for years 3 to 5. Medical imaging (thoracic and abdominal CT) should be performed 1 year postoperatively. Changes to the Dutch national guidelines during the course of the study will be implemented accordingly into the follow-up.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years
- •Histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago
- •Scheduled or currently undergoing postoperative surveillance according to national guidelines
- •Written informed consent by the patient
- •Access to a smartphone
排除标准
- •Patients with a severely complicated postoperative course, needing in hospital follow- up longer than 6 months postoperatively
- •Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and/or thorax
- •Patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent
- •Patients with active implantable devices - e.g. pacemaker or implantable defibrillator
- •Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language
研究组 & 干预措施
Implementation of home-based follow-up
All patients within the PROMISE study are included in the 'experimental' arm. The study is set up as an implementation study, meaning that the home-based method of follow-up is applied to all patients in the study.
干预措施: Home-based follow-up (Other)
结局指标
主要结局
Quality of life
时间窗: 36 months
The primary outcome of this study is to evaluate non-inferiority of the study follow-up with respect to the EQ-5D-5L score at 36 months of follow-up, which starts within 6 months of resection of the primary tumour.
Number of in hospital visits
时间窗: 36 months
The second primary outcome consists of significantly decreasing the number of in-hospital appointments, by relocating this follow-up care to the home setting. This will be assessed at 36 months postoperatively.
次要结局
未报告次要终点
研究者
D.J. (Dirk) Grünhagen
Surgical oncologist, MD, PhD
Erasmus Medical Center