Prospective Validation of a Points Score System Predicting 30-day Survival
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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:
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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)
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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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Low-risk Low-risk:score 0-6 |
Diagnostic Test: Point score prediction tool for 30-day survival
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
|
| Intermediate-risk Intermediate-risk: score 7-13 |
Diagnostic Test: Point score prediction tool for 30-day survival
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
|
| High-risk High-risk:score 14-20 |
Diagnostic Test: Point score prediction tool for 30-day survival
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
|
Outcome Measures
Primary Outcome Measures
- 30-day survival of patients with a score of >14 (high-risk group) [From baseline to 30 days after enrollment]
The percentage of patients with a score of >14 who are living at 30 days following enrollment
Secondary Outcome Measures
- 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]
Review of medical records.
- 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]
Using the FACIT-Pal-14© questionnaire (Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 at time of consent
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Ability to provide written informed consent
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Metastatic cancer diagnosis referred to Radiation Oncology for palliative radiation therapy
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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:
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Patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted)
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Patients receiving definitive/curative course of radiation therapy
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Patients who self-report as pregnant or nursing females are excluded from this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IU Health West | Avon | Indiana | United States | 46123 |
| 2 | IU Health Joe and Shelly Schwarz Cancer Center | Carmel | Indiana | United States | 46032 |
| 3 | Indiana University Health Hospital | Indianapolis | Indiana | United States | 46202 |
| 4 | Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 5 | Methodist Hospital | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
Investigators
- Principal Investigator: Naoyuki Saito, MD PhD, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTO-IUSCCC-0763