Compassionate Same-Day Evaluation & Delivery of XRT for Bony Metastasis in Hospice Patients

Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients

This is a survey study to evaluate the feasibility and effectiveness of an affordable, $400 flat rate, same-day consultation, simulation, and delivery of a single fraction of palliative radiation therapy for patients with symptomatic bony metastatic disease who are currently enrolled in hospice. Treatment planning and delivery of palliative radiotherapy will utilize "standard of care" techniques.

Study Overview

• Status: Terminated
• Conditions: Symptomatic Osseous Bone Lesions From Any Malignancy
• Intervention / Treatment: Radiation: Radiation Therapy; Other: Quality-of-Life Assessment; Other: Survey Administration

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptomatic osseous bone lesion(s) from any malignancy, whether primary of metastatic, with histological confirmation of malignancy.
• Currently enrolled in hospice and referred for single fraction palliative radiotherapy.
• Performance status (to be evaluated by the radiation oncologist), Karnofsky Performance Scale ≥ 20 or ECOG Performance Scale < 5 .
• Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

• Pregnancy.
• Unable to understand English.
• Unable to complete forms with assistance.
• Concurrent enrollment in a study of pain management involving medications or devices.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (radiation therapy); This is a survey study to evaluate the feasibility and effectiveness of an affordable, $400 flat rate, same-day consultation, simulation, and delivery of a single fraction of palliative radiation therapy for patients with symptomatic bony metastatic disease who are currently enrolled in hospice. Treatment planning and delivery of palliative radiotherapy will utilize "standard of care" techniques. A physician survey of feasibility will be conducted on the treatment day. Patient surveys will conducted on the day of treatment and at 2 weeks, 4 weeks, 2 months, 3 months, 4 months, 5 months, and 6 months after treatment.

Radiation: Radiation Therapy; Undergo standard of care radiation therapy; Other Names: Irradiation; RT; Other: Quality-of-Life Assessment; The patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised.; Other: Survey Administration; The surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Treatment Delivery in the Same Day as Initial Evaluation	Patient evaluation will consist of surveys conducted at the time of treatment measured by the Radiation Oncologist Evaluation and Feasibility Assessments survey	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction	Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.	2 weeks
Evaluate the Treatment Influence on Patient Quality of Life	Evaluate the treatment influence on patient quality of life as measured by the ESAS.	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile	Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile	6 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Drew Moghanaki, MD, MPH, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Lung; Prostate; Breast; Urology; Chest
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: MCC-14596; NCI-2012-03117 (Registry Identifier: NCI CTRP)