Patient- Reported Outcomes After Fast Same-day Delivery of Palliative Radiotherapy Without Planning CT Using an Adaptive Delivery Platform (FAST-METS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of life of patients
研究概览
简要总结
Palliative radiotherapy is an effective treatment for patients with painful bone metastases. Standard workflows often involve long waiting times or multiple visits. Fast palliation completed during a single clinic visit can be achieved by omitting a planning CT scan, and using available diagnostic imaging for treatment planning. The adaptive treatment platforms provides the possibility to adapt positions differences between the diagnostic CT and radiotherapy treatment of the target and organs at risk. In this study, the investigators will investigate the experiences of patients who have been treated with this fast-adaptive workflow (FAST-METS) using 2 questionnaires.
详细描述
Palliative radiotherapy is an effective treatment for patients with painful bone metastases, and currently the investigators have clinically implemented the FAST-METS procedure at the department. All patients referred for palliative radiotherapy, in whom diagnostic imaging performed within 4 weeks is available, are eligible for this adaptive workflow. Consultation by telephone is done beforehand to verify whether the complaints correspond to the location of the metastasis.
This single-institutional, explorative study will investigate the experiences and quality of life of patients who were treated with this workflow. Two study questionnaires are used, and informed consent will be obtained for both. The EQ-5D-5L questionnaire will be completed on the day of treatment, after 6 weeks and 3 months post-treatment. The other questionnaire used was developed for patients treated with adaptive radiotherapy. Two patients groups will be studied, namely those undergoing simple and complex palliative radiotherapy. Patients treated with complex palliative radiotherapy are defined as those referred for re-irradiation to the site of metastasis, patients undergoing concurrent systemic therapy, and patients treated with a single fraction radiation dose exceeding 8 Gy.
In addition, the study will evaluate time spent on treatment preparation and delivery proces, and dosimetric aspects of the treatment.
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
- •Patients referred for palliative radiotherapy to metastases
- •Recent diagnostic CT scan (preferably <4 weeks) of the metastasis with full body contour of the patient included.
排除标准
- •A solitairy metastasis from a primairy tumor with good a prognosis
- •A metastasis located in ventral ribs where respiratory motion of the target is expected
- •Patients who are not fluent in Dutch
结局指标
主要结局
Quality of life of patients
时间窗: 3 months
Quality of life, with EQ-5D-5L questionnaires. The questionnaires comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Satisfaction of patients
时间窗: 1 week
Measure the satisfaction of patients who are treated with FAST-METS workflow, using a patient questionnaire developed in-house, which is completed on the day of treatment. Each question has 5 levels: not satisfied at all, some satisfaction, reasonably satisfied, and very satisfied
次要结局
- Dosimetric data(1 week)
- Time spent on treatment preparation and delivery proces(1 week)
研究者
Suresh Senan
Principal Investigator, Clinical professor
Amsterdam UMC, location VUmc