| Primary | Rate of Local Control | | Participants must have received treatment and had a 6 month disease assessment to be evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At 6 months | | | | ID | Title | Description |
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| OG000 | SBRT | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. |
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| Primary | Number of Participants With Treatment-related, Non-hematologic Grade ≥ 3 Toxicity | | | Posted | | Count of Participants | | Participants | | Through 6 months | | | | ID | Title | Description |
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| OG000 | SBRT | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. |
| | | Title | Denominators | Categories |
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| Secondary | Mean Change From Baseline - PROMIS Physical Function Assessment |
- Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score.
- PROMIS Physical Function is a 10-item questionnaire assessing current self-reported physical function with answers ranging from 1 = cannot do to 5 = not at all/without any difficulty.
- A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation.
- A high T-Score for PROMIS Physical Function Assessment correlates to a higher physical function, or positive outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or better functioning, than the reference population mean.
| If a participant did not complete the questionnaire at the timepoint then they are not included. | Posted | | Mean | Standard Deviation | T-Score | | 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | SBRT-2 Weeks Post Treatment | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG001 | SBRT-30 Days | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG002 | SBRT-3 Months |
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| Secondary | Mean Change From Baseline-PROMIS Global Health Physical Assessment |
- Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score.
- PROMIS Global Health is a 2-item questionnaire assessing current self-reported physical function with answers ranging from 1=poor/not all all to 5=excellent/completely
- A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation.
- A high T-Score for PROMIS Global Health Physical Assessment correlates to a higher global health physical assessment, or positive outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or better physical assessment, than the reference population mean
| If a participant did not complete the questionnaire at the timepoint then they are not included. | Posted | | Mean | Standard Deviation | T-Score | | 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | SBRT-2 Weeks Post Treatment | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG001 | SBRT-30 Days | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG002 | SBRT-3 Months |
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| Secondary | Mean Change From Baseline-PROMIS Depression Assessment |
- Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score.
- PROMIS Depression is a 4-item questionnaire assessing current self-reported depression with answers ranging from 1=never to 5=always
- A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation.
- A high T-Score for PROMIS Depression Assessment correlates to more depression, or negative outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or worse depression, than the reference population mean
| If a participant did not complete the questionnaire at the timepoint then they are not included. | Posted | | Mean | Standard Deviation | T-Score | | 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | SBRT-2 Weeks Post Treatment | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG001 | SBRT-30 Days | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG002 | SBRT-3 Months | |
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| Secondary | Mean Change From Baseline-PROMIS Anxiety Assessment |
- Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score.
- PROMIS Anxiety is a 29-item questionnaire assessing current self-reported anxiety with answers ranging from 1=never to 5=always
- A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation.
- A high T-Score for PROMIS Anxiety Assessment correlates to more anxiety, or negative outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or worse anxiety, than the reference population mean.
| If a participant did not complete the questionnaire at the timepoint then they are not included. | Posted | | Mean | Standard Deviation | T-Score | | 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | SBRT-2 Weeks Post Treatment | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG001 | SBRT-30 Days | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG002 | SBRT-3 Months | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. |
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| Secondary | Mean Change From Baseline-Numeric Pain Scale |
- Each value is the mean of the changes from baseline Numeric Pain Scale score to timepoint Numeric Pain Scale score.
- The Numeric Pain Scale is an 11-point scale for patient self-reporting of pain
- The Numeric Pain Rating Scale (NPRS) measures pain intensity in adults using a scale from 0 or "no pain" to 10 or "worst possible pain." This measure is unidimensional and evaluated on the 0-10 scale. A higher value on the scale correlates with a worse pain and a worse outcome.
| If a participant did not complete the questionnaire at the timepoint then they are not included. | Posted | | Mean | Standard Deviation | score on a scale | | 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | SBRT-2 Weeks Post Treatment | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG001 | SBRT-30 Days | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG002 | SBRT-3 Months | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. |
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| Secondary | Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites) |
- The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms.
- Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5.
- Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5
- Frequency options include never=1, rarely=2, occasionally=3, frequently=4, almost constantly=5
| If a participant did not complete the questionnaire at the timepoint then they are not included. If the participant did not answer a question on the questionnaire then they are not included for that question. | Posted | | Median | Full Range | score on a scale | | Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | SBRT - Baseline | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG001 | SBRT - 2 Weeks Post-treatment | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG002 | SBRT - 30 Days | |
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| Secondary | Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites) |
- The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms.
- Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5.
- Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5
- How often options include 1=never, 2=rarely, 3=occasionally, 4=frequently, 5=almost constantly
- Severity of difficulty getting/keeping erection, ejaculation problems, decreased sexual interest, vaginal pain 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe
- Experienced unusual vaginal discharge options include 1=not at all, 2=a little bit, 3 = somewhat, 4=quite a bit, 5=very much
| If a participant did not complete the questionnaire at the timepoint then they are not included. If the participant did not answer a question on the questionnaire then they are not included for that question. | Posted | | Median | Full Range | score on a scale | | Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | SBRT - Baseline | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG001 | SBRT - 2 Weeks Post-treatment | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. |
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| Secondary | Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites) |
- The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms.
- Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5.
- Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5
- Frequency options include never=1, rarely=2, occasionally=3, frequently=4, almost constantly=5
| If a participant did not complete the questionnaire at the timepoint then they are not included. If the participant did not answer a question on the questionnaire then they are not included for that question. | Posted | | Median | Full Range | score on a scale | | Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | SBRT - Baseline | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG001 | SBRT - 2 Weeks Post-treatment | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG002 | SBRT - 30 Days | |
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| Secondary | Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites) |
- The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms.
- Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5.
- Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5
- Frequency options include never=1, rarely=2, occasionally=3, frequently=4, almost constantly=5
| If a participant did not complete the questionnaire at the timepoint then they are not included. | Posted | | Median | Full Range | score on a scale | | Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | SBRT - Baseline | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG001 | SBRT - 2 Weeks Post-treatment | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. | | OG002 | SBRT - 30 Days | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. |
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