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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04049188
Recruitment Status : Unknown
Verified January 2020 by Care Partners.
Recruitment status was:  Recruiting
First Posted : August 8, 2019
Last Update Posted : January 23, 2020
Sponsor:
Collaborators:
OHSU Knight Cancer Institute
Oregon Health and Science University
Information provided by (Responsible Party):
Care Partners

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

Condition or disease Intervention/treatment Phase
Cancer Metastatic Radiation: Single-Fraction Palliative Radiation Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Opioid Use for Pain Management [ Time Frame: Through study completion, an average of 1 year ]
    Opioid Dosage (mg/day)


Secondary Outcome Measures :
  1. Improved Quality of Life Measures [ Time Frame: During study completion ]
    Questionnaires using Herth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale

  2. Improved Activities of Daily Living [ Time Frame: During study completion ]
    Questionnaires using Hearth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049188


Contacts
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Contact: Andy Kyler, BSN, MBA 5036192621 andy.kyler@carepartners.org
Contact: Christa Nicholas 5036469565 Christa.Nicholas@carepartnersor.org

Locations
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United States, Oregon
CarePartners Recruiting
Hillsboro, Oregon, United States, 97006
Contact: Christa Nicholas    503-648-9565      
Principal Investigator: Andy Kyler, BSN, MBA         
Sponsors and Collaborators
Care Partners
OHSU Knight Cancer Institute
Oregon Health and Science University
More Information
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Responsible Party: Care Partners
ClinicalTrials.gov Identifier: NCT04049188    
Other Study ID Numbers: 00019460
20181015 ( Other Grant/Funding Number: Knight Cancer Institute - Community Partnership Program )
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Care Partners:
Cancer Patients Hospice Care
Palliative Radiation Therapy