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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Symptomatic Osseous Bone Lesions From Any Malignancy | Radiation: Radiation Therapy Other: Quality-of-Life Assessment Other: Survey Administration | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
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 |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | June 2015 |

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.
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Radiation: Radiation Therapy
Undergo standard of care radiation therapy
Other Names:
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. |
- 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
- 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.
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Virginia | |
Virginia Commonwealth University/Massey Cancer Center | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Drew Moghanaki, MD, MPH | Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT01760941 |
Other Study ID Numbers: |
MCC-14596 NCI-2012-03117 ( Registry Identifier: NCI CTRP ) |
First Posted: | January 4, 2013 Key Record Dates |
Results First Posted: | February 29, 2016 |
Last Update Posted: | February 29, 2016 |
Last Verified: | January 2016 |
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