Clinical trial NCT05100342: Prospective Validation of a Points Score System Predicting 30-day Survival
Official title: Prospective Validation of a Points Score System Predicting 30-day Survival for Patients with Metastatic Cancer Receiving Palliative Radiation Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Cancer
Keywords: palliative radiation
radiation therapy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: 30-day survival of patients with a score of >14 (high-risk group)
timeFrame: From baseline to 30 days after enrollment
Secondary outcomes:
measure: 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
timeFrame: 30 days, 90 days and 365 days after enrollment
measure: Tabulated patient-report quality of life surveys at 30 days, 90 days, and 365 days
timeFrame: Baseline, 30 days, 90 days and 365 days after enrollment
Other outcomes:
Locations:
city: Avon
country: United States
facility: IU Health West
state: Indiana
city: Carmel
country: United States
facility: IU Health North / Schwarz Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Naoyuki Saito, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: