跳至主要内容
临床试验/NCT05100342
NCT05100342招募中不适用

Prospective Validation of a Points Score System Predicting 30-day Survival for Patients With Metastatic Cancer Receiving Palliative Radiation Therapy

Indiana University4 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2022年9月12日最近更新:
适应症
干预措施

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:

  1. 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)
  2. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naoyuki G. Saito, M.D., Ph.D.

Assistant Professor of Radiation Oncology

Indiana University

研究点 (4)

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