Back to resultsCompassionate Same-Day Evaluation & Delivery of XRT for Bony Metastasis in Hospice Patients
Primary Purpose
Symptomatic Osseous Bone Lesions From Any Malignancy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Quality-of-Life Assessment
Survey Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Symptomatic Osseous Bone Lesions From Any Malignancy focused on measuring Urology, Prostate, Breast, Lung, Chest
Eligibility 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.
Sites / Locations
- Virginia Commonwealth University/Massey Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (radiation therapy)
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Evaluate the Treatment Influence on Patient Quality of Life
Evaluate the treatment influence on patient quality of life as measured by the ESAS.
Full Information
NCT ID
NCT01760941
First Posted
December 20, 2012
Last Updated
January 29, 2016
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT01760941
Brief Title
Compassionate Same-Day Evaluation & Delivery of XRT for Bony Metastasis in Hospice Patients
Official Title
Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Osseous Bone Lesions From Any Malignancy
Keywords
Urology, Prostate, Breast, Lung, Chest
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (radiation therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
RT, Irradiation
Intervention Description
Undergo standard of care radiation therapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
The patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised.
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
The surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey.
Primary Outcome Measure Information:
Title
Feasibility of Treatment Delivery in the Same Day as Initial Evaluation
Description
Patient evaluation will consist of surveys conducted at the time of treatment measured by the Radiation Oncologist Evaluation and Feasibility Assessments survey
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction
Description
Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.
Time Frame
2 weeks
Title
Evaluate the Treatment Influence on Patient Quality of Life
Description
Evaluate the treatment influence on patient quality of life as measured by the ESAS.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile
Description
Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drew Moghanaki, MD, MPH
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Compassionate Same-Day Evaluation & Delivery of XRT for Bony Metastasis in Hospice Patients
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