TriangleNCT02101788 · OUTCOME
Patients Reported Acute Quality of Life
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- 1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.
What was measured
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
Analysis population: Patients who provided baseline and ≥ 1 follow-up assessment
Groups in this outcome
Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan)
Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B. Letrozole: Given PO Paclitaxel: Given IV Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies Tamoxifen: Given PO Tamoxifen Citrate: Given PO Topotecan: Given IV Topotecan Hydrochloride: Given IV
Arm B (Trametinib)
Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment: Ancillary studies Trametinib: Given PO Trametinib Dimethyl Sulfoxide: Given PO
| Group | Source count |
|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 98 |
| Arm B (Trametinib) | 100 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 74.5 | 16.6 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 74.5 | 13.7 | Not reported | Not reported | Not reported |
12 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 74.2 | 16.0 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 70.6 | 13.5 | Not reported | Not reported | Not reported |
24 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 70.2 | 15.5 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 73.0 | 12.8 | Not reported | Not reported | Not reported |
36 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 69.3 | 18.6 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 72.6 | 12.8 | Not reported | Not reported | Not reported |
52 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan) | 72.1 | 16.9 | Not reported | Not reported | Not reported |
| Arm B (Trametinib) | 73.3 | 14.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.6
- value
- 74.5
- group Id
- OG001
- spread
- 13.7
- value
- 74.5
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 16.0
- value
- 74.2
- group Id
- OG001
- spread
- 13.5
- value
- 70.6
- title
- 12 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 15.5
- value
- 70.2
- group Id
- OG001
- spread
- 12.8
- value
- 73.0
- title
- 24 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 18.6
- value
- 69.3
- group Id
- OG001
- spread
- 12.8
- value
- 72.6
- title
- 36 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 16.9
- value
- 72.1
- group Id
- OG001
- spread
- 14.3
- value
- 73.3
- title
- 52 Weeks
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 100
- units
- Participants
- description
- Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B. Letrozole: Given PO Paclitaxel: Given IV Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies Tamoxifen: Given PO Tamoxifen Citrate: Given PO Topotecan: Given IV Topotecan Hydrochloride: Given IV
- id
- OG000
- title
- Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan)
- description
- Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment: Ancillary studies Trametinib: Given PO Trametinib Dimethyl Sulfoxide: Given PO
- id
- OG001
- title
- Arm B (Trametinib)
- param Type
- MEAN
- population Description
- Patients who provided baseline and ≥ 1 follow-up assessment
- reporting Status
- POSTED
- time Frame
- 1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.
- title
- Patients Reported Acute Quality of Life
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice