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NCT00265941 · OUTCOME

Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D)

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2022-06-14

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 Deviation
Time frame
3 months and 12 months

What was measured

The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state).

Analysis population: Randomized eligible patients with EQ-5D data at the given time point.

Groups in this outcome

RT + Cisplatin

Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin

RT + Cisplatin + Cetuximab

Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab

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

Analysis denominator · Participants

GroupSource count
RT + Cisplatin447
RT + Cisplatin + Cetuximab444

Reported measurements

EQ-5D 3 months

Analysis denominator · Participants

GroupSource count
RT + Cisplatin316
RT + Cisplatin + Cetuximab289
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
RT + Cisplatin0.780.18Not reportedNot reportedNot reported
RT + Cisplatin + Cetuximab0.770.15Not reportedNot reportedNot reported
EQ-5D 12 months

Analysis denominator · Participants

GroupSource count
RT + Cisplatin243
RT + Cisplatin + Cetuximab253
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
RT + Cisplatin0.840.17Not reportedNot reportedNot reported
RT + Cisplatin + Cetuximab0.840.16Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    3 months
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.74
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Kolmogorov-Smirnov
  2. group Description
    12 months
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.99
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Kolmogorov-Smirnov
Complete source fields
analyses
  1. group Description
    3 months
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.74
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Kolmogorov-Smirnov
  2. group Description
    12 months
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.99
    statistical Comment
    2-sided significance level of 0.05
    statistical Method
    Kolmogorov-Smirnov
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.18
        value
        0.78
      2. group Id
        OG001
        spread
        0.15
        value
        0.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        289
      units
      Participants
    title
    EQ-5D 3 months
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.17
        value
        0.84
      2. group Id
        OG001
        spread
        0.16
        value
        0.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        243
      2. group Id
        OG001
        value
        253
      units
      Participants
    title
    EQ-5D 12 months
denoms
  1. counts
    1. group Id
      OG000
      value
      447
    2. group Id
      OG001
      value
      444
    units
    Participants
description
The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state).
dispersion Type
Standard Deviation
groups
  1. description
    Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
    id
    OG000
    title
    RT + Cisplatin
  2. description
    Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
    id
    OG001
    title
    RT + Cisplatin + Cetuximab
param Type
MEAN
population Description
Randomized eligible patients with EQ-5D data at the given time point.
reporting Status
POSTED
time Frame
3 months and 12 months
title
Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D)
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice