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NCT00721513 · OUTCOME

Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)

Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer · Source last updated 2020-04-07

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
95% Confidence Interval
Time frame
Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years

What was measured

Four subscales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". Overall quality of life is the sum of the core items of the FACT-G possible range of 0-108 points. The higher the score the better the quality life. This interval includes 0, we will conclude that there is not conclusive statistical evidence that there is an improvement or worsening. If the interval does not include 0 we can determine whether there was a significant improvement (or worsening) depending on which side of the 0 the interval is on. The total outcome index score (possible range 0-108 points) is the sum of the physical and functional well being and additional concerns categories from the FACT-G.

Analysis population: This data was not collected on all participants.

Groups in this outcome

TPFChemotherapy + Concomitant Cetuximab & RT

Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy cetuximab cisplatin docetaxel fluorouracil computed tomography positron emission tomography quality-of-life assessment 3-dimensional conformal radiation therapy intensity-modulated radiation therapy

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

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT16

Reported measurements

Baseline - Physical Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT16
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT17.21Not reported13.1421.25Not reported
Baseline - Social/Family Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT16
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT23.66Not reported21.4025.92Not reported
Baseline - Emotional Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT16
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT17.00Not reported14.3019.70Not reported
Baseline Functional Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT16
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT17.48Not reported14.0020.95Not reported
Baseline Total Fact-G Score

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT16
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT75.35Not reported65.8484.86Not reported
Baseline Additional Concerns

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT16
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT23.25Not reported18.6727.83Not reported
Total Outcome Index Score - Baseline

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT16
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT57.94Not reported48.0567.82Not reported
Pre-RT Physical Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT9
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT15.56Not reported10.5920.52Not reported
Pre-RT Social/Family Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT10
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT23.90Not reported21.2426.56Not reported
Pre-RT Emotional Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT10
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT18.80Not reported15.5522.05Not reported
Pre-RT Functional Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT10
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT15.63Not reported11.5519.72Not reported
Pre-RT Total Fact-G Score

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT9
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT72.00Not reported59.1384.87Not reported
Pre-RT Additional Concerns

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT9
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT25.44Not reported20.4330.46Not reported
Total Outcome Index Score - Pre-RT

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT9
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT55.78Not reported44.7966.76Not reported
Post-RT Social/Family Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT12
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT23.80Not reported20.7426.86Not reported
Post-RT Physical Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT12
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT16.42Not reported11.0821.75Not reported
Post-RT Emotional Well-Bein

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT12
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT18.93Not reported16.1021.77Not reported
Post-RT Functional Well-Being

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT12
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT15.92Not reported10.7221.11Not reported
Post-RT FACT-G Total Score

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT12
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT75.07Not reported60.1789.97Not reported
Post-RT Additional Concerns

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT12
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT21.28Not reported15.4027.16Not reported
Total Outcome Index Score - Post- RT

Analysis denominator · Participants

GroupSource count
TPFChemotherapy + Concomitant Cetuximab & RT12
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TPFChemotherapy + Concomitant Cetuximab & RT50.00Not reported-22.63122.63Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.14
        upper Limit
        21.25
        value
        17.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Baseline - Physical Well-Being
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.40
        upper Limit
        25.92
        value
        23.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Baseline - Social/Family Well-Being
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.30
        upper Limit
        19.70
        value
        17.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Baseline - Emotional Well-Being
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.00
        upper Limit
        20.95
        value
        17.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Baseline Functional Well-Being
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.84
        upper Limit
        84.86
        value
        75.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Baseline Total Fact-G Score
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.67
        upper Limit
        27.83
        value
        23.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Baseline Additional Concerns
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.05
        upper Limit
        67.82
        value
        57.94
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Total Outcome Index Score - Baseline
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.59
        upper Limit
        20.52
        value
        15.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Pre-RT Physical Well-Being
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.24
        upper Limit
        26.56
        value
        23.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Pre-RT Social/Family Well-Being
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.55
        upper Limit
        22.05
        value
        18.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Pre-RT Emotional Well-Being
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.55
        upper Limit
        19.72
        value
        15.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Pre-RT Functional Well-Being
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.13
        upper Limit
        84.87
        value
        72.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Pre-RT Total Fact-G Score
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Four subscales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". Overall quality of life is the sum of the core items of the FACT-G possible range of 0-108 points. The higher the score the better the quality life. This interval includes 0, we will conclude that there is not conclusive statistical evidence that there is an improvement or worsening. If the interval does not include 0 we can determine whether there was a significant improvement (or worsening) depending on which side of the 0 the interval is on. The total outcome index score (possible range 0-108 points) is the sum of the physical and functional well being and additional concerns categories from the FACT-G.
dispersion Type
95% Confidence Interval
groups
  1. description
    Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy cetuximab cisplatin docetaxel fluorouracil computed tomography positron emission tomography quality-of-life assessment 3-dimensional conformal radiation therapy intensity-modulated radiation therapy
    id
    OG000
    title
    TPFChemotherapy + Concomitant Cetuximab & RT
param Type
MEAN
population Description
This data was not collected on all participants.
reporting Status
POSTED
time Frame
Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years
title
Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)
type
SECONDARY
unit Of Measure
Score on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice