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

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: NCT01760941
Recruitment Status : Terminated (Slow accrual)
First Posted : January 4, 2013
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE December 20, 2012
First Posted Date  ICMJE January 4, 2013
Results First Submitted Date  ICMJE December 18, 2015
Results First Posted Date  ICMJE February 29, 2016
Last Update Posted Date February 29, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • 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 MSAS.
Current Other Pre-specified Outcome Measures
 (submitted: January 2, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Compassionate Same-Day Evaluation & Delivery of XRT for Bony Metastasis in Hospice Patients
Official Title  ICMJE Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Symptomatic Osseous Bone Lesions From Any Malignancy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Radiation: Radiation Therapy
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 11, 2015)
1
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2013)
21
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760941
Other Study ID Numbers  ICMJE MCC-14596
NCI-2012-03117 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Drew Moghanaki, MD, MPH Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP