Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice (SFPRT)

January 21, 2020 updated by: Care Partners

Impact of Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice

Feasibility study to report on the impact of ACCESS of single-fraction radiation therapy on cancer patients with bone metastases enrolled in hospice care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hospice care for terminally ill patients with metastatic cancer improves quality of life, pain control, and potentially also survival when patients are enrolled early.1-3 However, hospice programs are often seen by patients and their caregivers as the last resort after exhaustion of all effective treatment options. The need to revoke active treatment (for all hospice patients with cancer outside of the VA system) discourages hospice enrollment.

This study aims to understand and analyze barriers to access specifically for short course palliative radiation therapy in cancer patients enrolled in hospice.

Study Type

Interventional

Enrollment (Anticipated)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Hillsboro, Oregon, United States, 97006
        • Recruiting
        • CarePartners
        • Contact:
          • Christa Nicholas
          • Phone Number: 503-648-9565
        • Principal Investigator:
          • Andy Kyler, BSN, MBA

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Solid Tumor Malignancies and Multiple Myeloma with Bone Metastases and Associated Bone Pain Enrolled in Hospice

Exclusion Criteria:

  • Decisionally-Impaired Subjects, Pregnant Women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-Fraction Palliative RT
Single-Fraction Palliative Radiation Therapy Adminstration
Radiation: Single-Fraction Palliative Radiation Therapy
All subjects will be undergo single-fraction palliative radiation therapy who have cancer and associated bone metastases and symptomatic bone pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Opioid Use for Pain Management
Time Frame: Through study completion, an average of 1 year
Opioid Dosage (mg/day)
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved Quality of Life Measures
Time Frame: During study completion
Questionnaires using Herth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale
During study completion
Improved Activities of Daily Living
Time Frame: During study completion
Questionnaires using Hearth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale
During study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Care Partners

Collaborators

Oregon Health and Science University
OHSU Knight Cancer Institute

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 Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00019460
  • 20181015 (Other Grant/Funding Number: Knight Cancer Institute - Community Partnership Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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