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

• Sponsor: Care Partners (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04049188
• Collaborator: OHSU Knight Cancer Institute (Other), Oregon Health and Science University (Other)
• Enrollment: 31
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Jan 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Change in Opioid Use for Pain Management [Through study completion, an average of 1 year]

   Opioid Dosage (mg/day)

Secondary Outcome Measures

1. Improved Quality of Life Measures [During study completion]

   Questionnaires using Herth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale

2. Improved Activities of Daily Living [During study completion]

   Questionnaires using Hearth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	CarePartners	Hillsboro	Oregon	United States	97006

Sponsors and Collaborators

• Care Partners
• OHSU Knight Cancer Institute
• Oregon Health and Science University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Care Partners
• ClinicalTrials.gov Identifier: NCT04049188
• Other Study ID Numbers: 00019460; 20181015
• First Posted: Aug 8, 2019
• Last Update Posted: Jan 23, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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

Study Results

No Results Posted as of Jan 23, 2020