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

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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

December 20, 2012
January 4, 2013
December 18, 2015
February 29, 2016
February 29, 2016
March 2013
January 2015   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01760941 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
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
Same as current
 
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Symptomatic Osseous Bone Lesions From Any Malignancy
  • 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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
21
June 2015
January 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01760941
MCC-14596
NCI-2012-03117 ( Registry Identifier: NCI CTRP )
Yes
Not Provided
Not Provided
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Drew Moghanaki, MD, MPH Virginia Commonwealth University
Virginia Commonwealth University
January 2016

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