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

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility of a Compassionate Same-Day Evaluation and Delivery of Single Fraction Radiotherapy for Palliation of Symptomatic Bony Metastasis in Hospice Patients

Conditions
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Symptomatic Osseous Bone Lesions From Any Malignancy

Intervention / Treatment
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* Radiation: Radiation Therapy
* Other: Quality-of-Life Assessment
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (radiation therapy)<br>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<br>* Undergo standard of care radiation therapy<br>* Other names: Irradiation;Other: Quality-of-Life Assessment<br>* The patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised.<br>Other: Survey Administration<br>* The surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 
| Evaluate the Treatment Influence on Patient Quality of Life | Evaluate the treatment influence on patient quality of life as measured by the ESAS. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urology, Prostate, Breast, Lung, Chest