Symptomatic Osseous Bone Lesions From Any Malignancy
Conditions
Keywords
Urology, Prostate, Breast, Lung, Chest
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.
Interventions
RADIATIONRadiation Therapy
Undergo standard of care radiation therapy
OTHERQuality-of-Life Assessment
The patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised.
OTHERSurvey Administration
The surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Treatment Delivery in the Same Day as Initial Evaluation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction | 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 | 2 weeks | Evaluate the treatment influence on patient quality of life as measured by the ESAS. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile | 6 months | Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Radiotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: Up to 6 months
Secondary
Evaluate the Treatment Influence on Patient Quality of Life
Evaluate the treatment influence on patient quality of life as measured by the ESAS.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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
Time frame: 6 months