RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

Prospective Validation of a Points Score System Predicting 30-day Survival for Patients With Metastatic Cancer Receiving Palliative Radiation Therapy

Quick Facts

Study Start:2022-09-12
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05100342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 at time of consent
  2. 2. Ability to provide written informed consent
  3. 3. Cancer diagnosis referred to Radiation Oncology for palliative radiation therapy
  4. 4. Patients who either choose to not receive radiation therapy or not recommended to receive radiation therapy will remain eligible
  5. 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
  1. 1. Patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted)
  2. 2. Patients who are receiving definitive/curative course of radiation therapy
  3. 3. Patients who self-report as pregnant or nursing

Contacts and Locations

Study Contact

Nikki Barrow
CONTACT
317-944-0260
nrbarrow@iu.edu
Naoyuki G Saito, MD PhD
CONTACT

Principal Investigator

Naoyuki Saito, MD PhD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

IU Health West
Avon, Indiana, 46123
United States
IU Health North / Schwarz Cancer Center
Carmel, Indiana, 46032
United States
Indiana University Health Hospital
Indianapolis, Indiana, 46202
United States
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
Methodist Hospital
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Naoyuki Saito, MD PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-12
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-09-12
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • palliative radiation
  • radiation therapy

Additional Relevant MeSH Terms

  • Metastatic Cancer