Overview
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.
Description
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:
- 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)
Eligibility
Inclusion Criteria:
- Age ≥ 18 at time of consent
- Ability to provide written informed consent
- Metastatic cancer diagnosis referred to Radiation Oncology for palliative radiation therapy
- Patients, as assessed by the radiation oncologist, who present with symptoms secondary to cancer that can be palliated by radiation therapy 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
Exclusion Criteria:
- Patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted)
- Patients receiving definitive/curative course of radiation therapy
- Patients who self-report as pregnant or nursing females are excluded from this study.