Prospective Validation of a Points Score System Predicting 30-day Survival
N
Naoyuki Saito, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
2
57 participants needed
4 Locations
Brief description of study
What is the purpose of this study?
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 oncologyve treatments. Survival prediction score based on objective data includingboratory values, attendance to emergency room, and primary cancer origin will be assigned patient at time of enrollment.
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),d intermediate-risk (score 7-13) groups, and to evaluate 90-day and 365-day survivalhigh-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)
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- Survival prediction score based on objective data including laboratory values, visits to emergency room, and primary cancer origin will begned to each patient at time of enrollment.
- The prediction tool assigns a score from20, with 20 indicating the worst survival prognosis; the investigators have designatedy 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>14 have a less than 20% chance of survival at 30 days.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Metastatic Cancer
-
Age: 18 Years
-
Gender: All
Inclusion Criteria:
- Age ≥ 18 at time of consent
- Ability to provide written informed consent
- Metastatic cancer diagnosis referred to Radiation Oncology for palliative radiationherapy
- Patients, as assessed by the radiation oncologist, who present with symptoms secondaryhat can be palliated by radiation therapy Note: Patients who ultimatelyher choose to not receive radiation or not recommended to receive radiation willgible
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.
Updated on
01 Aug 2024.
Study ID: CTO-IUSCCC-0763, 12546
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