TriangleNCT00063999 · OUTCOME
Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment
What was measured
The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.
Analysis population: Eligible and evaluable and enrolled prior to 3/26/2006
Groups in this outcome
Arm I (Doxorubicin, Cisplatin, Paclitaxel)
Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Arm II (Paclitaxel, Carboplatin)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 228 |
| Arm II (Paclitaxel, Carboplatin) | 246 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 39.4 | 0.72 | Not reported | Not reported | Not reported |
| Arm II (Paclitaxel, Carboplatin) | 37.9 | 0.7 | Not reported | Not reported | Not reported |
6 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 35.5 | 0.73 | Not reported | Not reported | Not reported |
| Arm II (Paclitaxel, Carboplatin) | 37.5 | 0.68 | Not reported | Not reported | Not reported |
15 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 35.3 | 0.74 | Not reported | Not reported | Not reported |
| Arm II (Paclitaxel, Carboplatin) | 36.5 | 0.7 | Not reported | Not reported | Not reported |
26 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 39.8 | 0.8 | Not reported | Not reported | Not reported |
| Arm II (Paclitaxel, Carboplatin) | 38.5 | 0.81 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.72
- value
- 39.4
- group Id
- OG001
- spread
- 0.7
- value
- 37.9
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.73
- value
- 35.5
- group Id
- OG001
- spread
- 0.68
- value
- 37.5
- title
- 6 weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.74
- value
- 35.3
- group Id
- OG001
- spread
- 0.7
- value
- 36.5
- title
- 15 weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.8
- value
- 39.8
- group Id
- OG001
- spread
- 0.81
- value
- 38.5
- title
- 26 weeks
- denoms
- counts
- group Id
- OG000
- value
- 228
- group Id
- OG001
- value
- 246
- units
- Participants
- description
- The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.
- dispersion Type
- Standard Error
- groups
- description
- Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I (Doxorubicin, Cisplatin, Paclitaxel)
- description
- Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm II (Paclitaxel, Carboplatin)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Eligible and evaluable and enrolled prior to 3/26/2006
- reporting Status
- POSTED
- time Frame
- Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment
- title
- Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice