TriangleNCT00807768 · OUTCOME
Patient-reported Quality of Life
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 study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment
What was measured
Patient reported quality of life as measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item in the FACT-En 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-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL
Analysis population: Provided baseline and \>= follow-up assessments
Groups in this outcome
Arm I (Pelvic Radiation Therapy)
Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Arm II (Brachytherapy, Paclitaxel, Carboplatin)
Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
| Group | Source count |
|---|---|
| Arm I (Pelvic Radiation Therapy) | 263 |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 277 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 98.5 | 0.9 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 98.7 | 0.9 | Not reported | Not reported | Not reported |
4 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 91.0 | 0.9 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 92.2 | 0.8 | Not reported | Not reported | Not reported |
10-11 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 98.7 | 0.9 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 95.6 | 0.8 | Not reported | Not reported | Not reported |
8 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 101.5 | 0.8 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 99.9 | 0.9 | Not reported | Not reported | Not reported |
14 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 99.7 | 1.0 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 102.1 | 0.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.9
- value
- 98.5
- group Id
- OG001
- spread
- 0.9
- value
- 98.7
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.9
- value
- 91.0
- group Id
- OG001
- spread
- 0.8
- value
- 92.2
- title
- 4 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.9
- value
- 98.7
- group Id
- OG001
- spread
- 0.8
- value
- 95.6
- title
- 10-11 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.8
- value
- 101.5
- group Id
- OG001
- spread
- 0.9
- value
- 99.9
- title
- 8 Months
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- 99.7
- group Id
- OG001
- spread
- 0.9
- value
- 102.1
- title
- 14 Months
- denoms
- counts
- group Id
- OG000
- value
- 263
- group Id
- OG001
- value
- 277
- units
- Participants
- description
- Patient reported quality of life as measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item in the FACT-En 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-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL
- dispersion Type
- Standard Error
- groups
- description
- Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG000
- title
- Arm I (Pelvic Radiation Therapy)
- description
- Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG001
- title
- Arm II (Brachytherapy, Paclitaxel, Carboplatin)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Provided baseline and \>= follow-up assessments
- reporting Status
- POSTED
- time Frame
- Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment
- title
- Patient-reported Quality of Life
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice