Prospective Validation of a Points Score System Predicting 30-day Survival for Patients With Metastatic Cancer Receiving Palliative Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 4
- 主要终点
- 30-day survival of patients with a score of >14 (high-risk group)
研究概览
简要总结
This is a one-stage single-arm phase II clinical trial designed to prospectively test the survival prediction tool as developed by Lee et al on patients referred to radiation oncology for palliative treatments. Survival prediction score based on objective data including laboratory values, attendance to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment.
详细描述
This is a one-stage single-arm phase II clinical trial designed to prospectively test the survival prediction tool as developed by Lee et al (section 10.0) on patients referred to radiation oncology for palliative treatments. Survival prediction score based on objective data including laboratory values, visits to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment. The prediction tool assigns a score from 0-20, with 20 indicating the worst survival prognosis; the investigators have designated mortality risk groups as follows: low-risk (score 0-6), intermediate-risk (score 7-13), and high-risk (score 14-20). Patient survival and quality of life will then be monitored at 30-day, 90-day, and 365-day intervals. The study will test the hypothesis that patients with a score of >14 have a less than 20% chance of survival at 30 days.
Primary Objective:
1. To evaluate 30-day survival of patients with a score of >14 (high-risk group)
Secondary Objectives:
- To evaluate 30-day, 90-day, and 365-day survival of patients in low-risk (score 0-6), and intermediate-risk (score 7-13) groups, and to evaluate 90-day and 365-day survival of patients in high-risk group (score >14)
- To evaluate patient-reported quality of life at the above intervals using the validated FACIT-Pal-14© questionnaire (Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 time of consent
- •Ability to provide written informed consent
- •Cancer diagnosis referred to Radiation Oncology for palliative radiation therapy
- •Patients who either choose to not receive radiation therapy or not recommended to receive radiation therapy will remain eligible
- •Those patients who undergo a course of palliative radiation therapy, it is not the requirement of this study to complete that course of treatment. Those who prematurely end their course of treatment will remain eligible Note: Patients who ultimately either choose to not receive radiation or not recommended to receive radiation will remain eligible
- •Note: Patients who ultimately do not complete prescribed radiation will remain eligible
排除标准
- •Patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted)
- •Patients who are receiving definitive/curative course of radiation therapy
- •Patients who self-report as pregnant or nursing
研究组 & 干预措施
High-risk
High-risk:score 14-20
干预措施: Point score prediction tool for 30-day survival (Diagnostic Test)
Low-risk
Low-risk:score 0-6
干预措施: Point score prediction tool for 30-day survival (Diagnostic Test)
Intermediate-risk
Intermediate-risk: score 7-13
干预措施: Point score prediction tool for 30-day survival (Diagnostic Test)
结局指标
主要结局
30-day survival of patients with a score of >14 (high-risk group)
时间窗: From baseline to 30 days after enrollment
The percentage of patients with a score of \>14 who are living at 30 days following enrollment
次要结局
- The percentage of patients in each risk group (low, intermediate, and high) who are living at 30 days, 90 days, and 365 days following enrollment(30 days, 90 days and 365 days after enrollment)
- Tabulated patient-report quality of life surveys at 30 days, 90 days, and 365 days(Baseline, 30 days, 90 days and 365 days after enrollment)
研究者
Naoyuki G. Saito, M.D., Ph.D.
Assistant Professor of Radiation Oncology
Indiana University
