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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-03117 | Registry Identifier | NCI CTRP |
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Slow accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (radiation therapy) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Undergo standard of care radiation therapy |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile | Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Drew Moghanaki, MD, MPH | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiotherapy | Single fraction radiotherapy Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment. planning. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiotherapy | Single fraction radiotherapy Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment. planning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Up to 6 months |
|
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As this is a survey study and not a drug study, changed from an "Adverse Events" section to a "Study Risks" section. No AEs or SAEs were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiotherapy | Single fraction radiotherapy Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment. planning. |
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No data analysis or outcome measures for one participant enrolled and zero participants analyzed. Early suspension and termination due to slow accrual from Protocol Review and Monitoring Committee.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Drew Moghanaki, MD, MPH | Virginia Commonwealth University/Massey Cancer Center | 804-765-5850 | Drew.moghanaki@vcuhealth.org |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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| Quality-of-Life Assessment | Other | The patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised. |
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| Survey Administration | Other | The surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey. |
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Evaluate the treatment influence on patient quality of life as measured by the ESAS. |
| 2 weeks |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Secondary | 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. | Posted | 2 weeks |
|
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| Secondary | Evaluate the Treatment Influence on Patient Quality of Life | Evaluate the treatment influence on patient quality of life as measured by the ESAS. | Posted | 2 weeks |
|
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| Other Pre-specified | Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile | Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile | Posted | 6 months |
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