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

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760941
First Posted: January 4, 2013
Last Update Posted: February 29, 2016
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.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
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.

Condition Intervention
Symptomatic Osseous Bone Lesions From Any Malignancy Radiation: Radiation Therapy Other: Quality-of-Life Assessment Other: Survey Administration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

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


Secondary Outcome Measures:
  • Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction [ Time Frame: 2 weeks ]
    Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.

  • Evaluate the Treatment Influence on Patient Quality of Life [ Time Frame: 2 weeks ]
    Evaluate the treatment influence on patient quality of life as measured by the ESAS.


Other Outcome Measures:
  • Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile [ Time Frame: 6 months ]
    Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile


Enrollment: 1
Study Start Date: March 2013
Study Completion Date: June 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • RT
  • Irradiation
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT01760941


Locations
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Drew Moghanaki, MD, MPH Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01760941     History of Changes
Other Study ID Numbers: MCC-14596
NCI-2012-03117 ( Registry Identifier: NCI CTRP )
First Submitted: December 20, 2012
First Posted: January 4, 2013
Results First Submitted: December 18, 2015
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016
Last Verified: January 2016

Keywords provided by Virginia Commonwealth University:
Urology
Prostate
Breast
Lung
Chest