TriangleNCT00064077 · OUTCOME
Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
What was measured
The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was 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 answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.
Analysis population: Patients who provided baseline and ≥ one follow-up assessments
Groups in this outcome
Arm I (Paclitaxel, Cisplatin)
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
Arm II (Vinorelbine, Cisplatin)
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
Arm III (Gemcitabine, Cisplatin)
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
Arm IV (Topotecan, Cisplatin)
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
| Group | Source count |
|---|---|
| Arm I (Paclitaxel, Cisplatin) | 86 |
| Arm II (Vinorelbine, Cisplatin) | 89 |
| Arm III (Gemcitabine, Cisplatin) | 92 |
| Arm IV (Topotecan, Cisplatin) | 96 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | 66.6 | 17.6 | Not reported | Not reported | Not reported |
| Arm II (Vinorelbine, Cisplatin) | 69.1 | 18.6 | Not reported | Not reported | Not reported |
| Arm III (Gemcitabine, Cisplatin) | 67.9 | 19.5 | Not reported | Not reported | Not reported |
| Arm IV (Topotecan, Cisplatin) | 68.1 | 19.2 | Not reported | Not reported | Not reported |
Pre-cycle 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | 65.2 | 17.6 | Not reported | Not reported | Not reported |
| Arm II (Vinorelbine, Cisplatin) | 65.5 | 15.8 | Not reported | Not reported | Not reported |
| Arm III (Gemcitabine, Cisplatin) | 65.3 | 18.2 | Not reported | Not reported | Not reported |
| Arm IV (Topotecan, Cisplatin) | 66.2 | 16.3 | Not reported | Not reported | Not reported |
Pre-cycle 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | 70.5 | 16.5 | Not reported | Not reported | Not reported |
| Arm II (Vinorelbine, Cisplatin) | 66.6 | 17.4 | Not reported | Not reported | Not reported |
| Arm III (Gemcitabine, Cisplatin) | 64.5 | 16.5 | Not reported | Not reported | Not reported |
| Arm IV (Topotecan, Cisplatin) | 68.4 | 15.5 | Not reported | Not reported | Not reported |
9 months post cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | 71.9 | 16.6 | Not reported | Not reported | Not reported |
| Arm II (Vinorelbine, Cisplatin) | 69.9 | 18.8 | Not reported | Not reported | Not reported |
| Arm III (Gemcitabine, Cisplatin) | 68.6 | 19.5 | Not reported | Not reported | Not reported |
| Arm IV (Topotecan, Cisplatin) | 70.9 | 17.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.6
- value
- 66.6
- group Id
- OG001
- spread
- 18.6
- value
- 69.1
- group Id
- OG002
- spread
- 19.5
- value
- 67.9
- group Id
- OG003
- spread
- 19.2
- value
- 68.1
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 17.6
- value
- 65.2
- group Id
- OG001
- spread
- 15.8
- value
- 65.5
- group Id
- OG002
- spread
- 18.2
- value
- 65.3
- group Id
- OG003
- spread
- 16.3
- value
- 66.2
- title
- Pre-cycle 2
- categories
- measurements
- group Id
- OG000
- spread
- 16.5
- value
- 70.5
- group Id
- OG001
- spread
- 17.4
- value
- 66.6
- group Id
- OG002
- spread
- 16.5
- value
- 64.5
- group Id
- OG003
- spread
- 15.5
- value
- 68.4
- title
- Pre-cycle 5
- categories
- measurements
- group Id
- OG000
- spread
- 16.6
- value
- 71.9
- group Id
- OG001
- spread
- 18.8
- value
- 69.9
- group Id
- OG002
- spread
- 19.5
- value
- 68.6
- group Id
- OG003
- spread
- 17.9
- value
- 70.9
- title
- 9 months post cycle 1
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 89
- group Id
- OG002
- value
- 92
- group Id
- OG003
- value
- 96
- units
- Participants
- description
- The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was 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 answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- OG000
- title
- Arm I (Paclitaxel, Cisplatin)
- description
- Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
- id
- OG001
- title
- Arm II (Vinorelbine, Cisplatin)
- description
- Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
- id
- OG002
- title
- Arm III (Gemcitabine, Cisplatin)
- description
- Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
- id
- OG003
- title
- Arm IV (Topotecan, Cisplatin)
- param Type
- MEAN
- population Description
- Patients who provided baseline and ≥ one follow-up assessments
- reporting Status
- POSTED
- time Frame
- Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
- title
- Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice