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NCT01167712 · OUTCOME

Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer · Source last updated 2026-05-29

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 Error
Time frame
18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks

What was measured

Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)

Analysis population: All individuals who did not opt for neo-adjuvant treatment and completed a baseline FACT-O TOI assessment and at least one follow-up assessment.

Groups in this outcome

Arm I (Adjuvant Chemotherapy Suboptimally Debulked)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV

Arm II (Neoadjuvant Chemotherapy)

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (Adjuvant Chemotherapy Suboptimally Debulked)292
Arm II (Neoadjuvant Chemotherapy)287

Reported measurements

Source class 1
Values in Units on a Scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Adjuvant Chemotherapy Suboptimally Debulked)70.91.42Not reportedNot reportedNot reported
Arm II (Neoadjuvant Chemotherapy)68.21.59Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.42
        value
        70.9
      2. group Id
        OG001
        spread
        1.59
        value
        68.2
denoms
  1. counts
    1. group Id
      OG000
      value
      292
    2. group Id
      OG001
      value
      287
    units
    Participants
description
Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)
dispersion Type
Standard Error
groups
  1. description
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV
    id
    OG000
    title
    Arm I (Adjuvant Chemotherapy Suboptimally Debulked)
  2. description
    Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
    id
    OG001
    title
    Arm II (Neoadjuvant Chemotherapy)
param Type
MEAN
population Description
All individuals who did not opt for neo-adjuvant treatment and completed a baseline FACT-O TOI assessment and at least one follow-up assessment.
reporting Status
POSTED
time Frame
18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks
title
Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)
type
SECONDARY
unit Of Measure
Units on a Scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice