TriangleNCT00565851 · OUTCOME
Patient Reported Quality of Life (Surgery Analysis)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.
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). Each item in the FACT-O 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). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
Analysis population: Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
Groups in this outcome
No Cytoreductive Surgery
All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
Cytoreductive Surgery
All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
| Group | Source count |
|---|---|
| No Cytoreductive Surgery | 215 |
| Cytoreductive Surgery | 206 |
Reported measurements
Prior to surgery
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Cytoreductive Surgery | 74.5 | 1.0 | Not reported | Not reported | Not reported |
| Cytoreductive Surgery | 74.2 | 1.0 | Not reported | Not reported | Not reported |
6 weeks post-surgery
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Cytoreductive Surgery | 69.3 | 1.3 | Not reported | Not reported | Not reported |
| Cytoreductive Surgery | 68.4 | 1.3 | Not reported | Not reported | Not reported |
15 weeks post-surgery
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Cytoreductive Surgery | 68.7 | 1.3 | Not reported | Not reported | Not reported |
| Cytoreductive Surgery | 68.8 | 1.3 | Not reported | Not reported | Not reported |
6 months post-surgery
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Cytoreductive Surgery | 72.6 | 1.3 | Not reported | Not reported | Not reported |
| Cytoreductive Surgery | 73.5 | 1.3 | Not reported | Not reported | Not reported |
12 months post-surgery
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Cytoreductive Surgery | 74.0 | 1.4 | Not reported | Not reported | Not reported |
| Cytoreductive Surgery | 75.6 | 1.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- 74.5
- group Id
- OG001
- spread
- 1.0
- value
- 74.2
- title
- Prior to surgery
- categories
- measurements
- group Id
- OG000
- spread
- 1.3
- value
- 69.3
- group Id
- OG001
- spread
- 1.3
- value
- 68.4
- title
- 6 weeks post-surgery
- categories
- measurements
- group Id
- OG000
- spread
- 1.3
- value
- 68.7
- group Id
- OG001
- spread
- 1.3
- value
- 68.8
- title
- 15 weeks post-surgery
- categories
- measurements
- group Id
- OG000
- spread
- 1.3
- value
- 72.6
- group Id
- OG001
- spread
- 1.3
- value
- 73.5
- title
- 6 months post-surgery
- categories
- measurements
- group Id
- OG000
- spread
- 1.4
- value
- 74.0
- group Id
- OG001
- spread
- 1.3
- value
- 75.6
- title
- 12 months post-surgery
- denoms
- counts
- group Id
- OG000
- value
- 215
- group Id
- OG001
- value
- 206
- 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). Each item in the FACT-O 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). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
- dispersion Type
- Standard Error
- groups
- description
- All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
- id
- OG000
- title
- No Cytoreductive Surgery
- description
- All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
- id
- OG001
- title
- Cytoreductive Surgery
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
- reporting Status
- POSTED
- time Frame
- 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.
- title
- Patient Reported Quality of Life (Surgery Analysis)
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice