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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-risk | Low-risk:score 0-6 |
| |
| Intermediate-risk | Intermediate-risk: score 7-13 |
| |
| High-risk | High-risk:score 14-20 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point score prediction tool for 30-day survival | Diagnostic Test | This tool requires laboratory data including white blood cell count, neutrophil-lymphocyte ratio, blood urea nitrogen, bilirubin, albumin, lactate dehydrogenase, and red cell distribution, as well as number of attendances to the emergency room in the past 100 days, the site receiving radiation therapy, and the primary cancer type. Each data point correlates with a point value, which are tallied to generate a final score. The scores range from 0-20, with 0 giving the highest chance for survival at 30 days and 20 giving the lowest chance for survival at 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day survival of patients with a score of >14 (high-risk group) | The percentage of patients with a score of >14 who are living at 30 days following enrollment | From baseline to 30 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Review of medical records. | 30 days, 90 days and 365 days after enrollment |
| Tabulated patient-report quality of life surveys at 30 days, 90 days, and 365 days |
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Inclusion Criteria:
Note: Patients who ultimately do not complete prescribed radiation will remain eligible
Exclusion Criteria:
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Potential patients will be identified and recruited per the recommendation of the consulting radiation oncologist at IUSCCC, IUH Methodist Hospital, Schwarz Cancer Center and IU West hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Anders | Contact | (317) 274-0220 | jemlynn@iu.edu | |
| Naoyuki G Saito, MD PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Naoyuki Saito, MD PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health West | Recruiting | Avon | Indiana | 46123 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Using the FACIT-Pal-14© questionnaire (Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version |
| Baseline, 30 days, 90 days and 365 days after enrollment |
| IU Health North / Schwarz Cancer Center | Recruiting | Carmel | Indiana | 46032 | United States |
|
| Methodist Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
|