TriangleNCT03870451 · OUTCOME
Feasibility - Ability to Complete Daily 30-minute Cryocompression Treatments
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of compliant participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to 8 weeks of cryocompression therapy
What was measured
The primary outcome measure will be feasibility of daily 30-minute cryocompression treatments with a target of 60% compliance. Compliance will be measured with patient diaries. Only periods for which diaries exist will be evaluated. Compliance is defined as completion of 60% of prescribed treatment days. Completion of at least 25 of 30 minutes on each day will be considered completion of therapy on the prescribed day. Analyses will be primarily descriptive to estimate variances and effect sizes for future work. The proportion of compliance and its 95% confidence interval will be calculated for each cohort.
Analysis population: Not all treated patients returned a diary leading to missing data.
Groups in this outcome
Grade 2-3 Established Neuropathy
VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
Grade 1-2 New-onset Neuropathy
VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
| Group | Source count |
|---|---|
| Grade 2-3 Established Neuropathy | 10 |
| Grade 1-2 New-onset Neuropathy | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Grade 2-3 Established Neuropathy | 100 | Not reported | 100 | 100 | Not reported |
| Grade 1-2 New-onset Neuropathy | 66.7 | Not reported | 4.3 | 77.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 100
- upper Limit
- 100
- value
- 100
- group Id
- OG001
- lower Limit
- 4.3
- upper Limit
- 77.7
- value
- 66.7
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- The primary outcome measure will be feasibility of daily 30-minute cryocompression treatments with a target of 60% compliance. Compliance will be measured with patient diaries. Only periods for which diaries exist will be evaluated. Compliance is defined as completion of 60% of prescribed treatment days. Completion of at least 25 of 30 minutes on each day will be considered completion of therapy on the prescribed day. Analyses will be primarily descriptive to estimate variances and effect sizes for future work. The proportion of compliance and its 95% confidence interval will be calculated for each cohort.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
- id
- OG000
- title
- Grade 2-3 Established Neuropathy
- description
- VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. VascuTherm5 vascular compression device: VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
- id
- OG001
- title
- Grade 1-2 New-onset Neuropathy
- param Type
- NUMBER
- population Description
- Not all treated patients returned a diary leading to missing data.
- reporting Status
- POSTED
- time Frame
- Baseline up to 8 weeks of cryocompression therapy
- title
- Feasibility - Ability to Complete Daily 30-minute Cryocompression Treatments
- type
- PRIMARY
- unit Of Measure
- percentage of compliant participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice