TriangleNCT01535053 · OUTCOME
Patient-reported Quality of Life (QOL) After Baseline Visit.
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
- Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.
What was measured
Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G 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, 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 FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
Analysis population: Provided baseline and ≥1 follow-up assessments
Groups in this outcome
Regimen I (Dactinomycin)
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
Regimen II (Methotrexate)
institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
| Group | Source count |
|---|---|
| Regimen I (Dactinomycin) | 27 |
| Regimen II (Methotrexate) | 27 |
Reported measurements
Pre-cycle 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen I (Dactinomycin) | 78.3 | 2.3 | Not reported | Not reported | Not reported |
| Regimen II (Methotrexate) | 81.6 | 2.7 | Not reported | Not reported | Not reported |
Pre-cycle 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen I (Dactinomycin) | 75.5 | 3.3 | Not reported | Not reported | Not reported |
| Regimen II (Methotrexate) | 78.9 | 2.8 | Not reported | Not reported | Not reported |
Pre-cycle 7
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen I (Dactinomycin) | 85.0 | 2.7 | Not reported | Not reported | Not reported |
| Regimen II (Methotrexate) | 84.5 | 2.2 | Not reported | Not reported | Not reported |
26 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen I (Dactinomycin) | 91.2 | 2.9 | Not reported | Not reported | Not reported |
| Regimen II (Methotrexate) | 90.9 | 2.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.3
- value
- 78.3
- group Id
- OG001
- spread
- 2.7
- value
- 81.6
- title
- Pre-cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 3.3
- value
- 75.5
- group Id
- OG001
- spread
- 2.8
- value
- 78.9
- title
- Pre-cycle 5
- categories
- measurements
- group Id
- OG000
- spread
- 2.7
- value
- 85.0
- group Id
- OG001
- spread
- 2.2
- value
- 84.5
- title
- Pre-cycle 7
- categories
- measurements
- group Id
- OG000
- spread
- 2.9
- value
- 91.2
- group Id
- OG001
- spread
- 2.9
- value
- 90.9
- title
- 26 weeks
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G 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, 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 FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
- dispersion Type
- Standard Error
- groups
- description
- IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
- id
- OG000
- title
- Regimen I (Dactinomycin)
- description
- institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
- id
- OG001
- title
- Regimen II (Methotrexate)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Provided baseline and ≥1 follow-up assessments
- reporting Status
- POSTED
- time Frame
- Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.
- title
- Patient-reported Quality of Life (QOL) After Baseline Visit.
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice