Prospective Validation of a Points Score System Predicting 30-day Survival

Recruiting

• Conditions: Metastatic Cancer
• Interventions: Diagnostic Test: Point score prediction tool for 30-day survival

• Registration Number: NCT05100342
• Lead Sponsor: Indiana University

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.

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:

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)

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Study Start: 2022-09-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Age ≥ 18 at time of consent
2. Ability to provide written informed consent
3. Cancer diagnosis referred to Radiation Oncology for palliative radiation therapy
4. Patients who either choose to not receive radiation therapy or not recommended to receive radiation therapy will remain eligible
5. 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

Exclusion Criteria

1. Patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted)
2. Patients who are receiving definitive/curative course of radiation therapy
3. Patients who self-report as pregnant or nursing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-risk	Point score prediction tool for 30-day survival	High-risk:score 14-20
Low-risk	Point score prediction tool for 30-day survival	Low-risk:score 0-6
Intermediate-risk	Point score prediction tool for 30-day survival	Intermediate-risk: score 7-13

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Indiana University Health Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

IU Health North / Schwarz Cancer Center; 🇺🇸 Carmel, Indiana, United States

Indiana University Health Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health West; 🇺🇸 Avon, Indiana, United States

Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States