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NCT00573989 · OUTCOME

Change in Quality of Life: MDADI

Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer · Source last updated 2019-01-03

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
baseline and 12 months

What was measured

The M.D. Anderson Dysphagia Inventory (MDADI) was used to assess effects of dysphagia on the quality of life of patients with head and neck cancer. It incorporates 3 domains (emotional, functional, and physical) as well as 1 global question. Each subscale with five possible responses scored on a scale of 1 to 5 (strongly agree, agree, no opinion, disagree and strongly disagree). Scores range from 0 (extremely low functioning) to 100 (higher functioning). Higher MDADI score represents better day-to-day functioning and better quality of life.

Analysis population: Data not collected on all participants at 12 months. Data corresponds to Phase II patients.

Groups in this outcome

Erlotinib

Erlotinib erlotinib hydrochloride pemetrexed disodium quality-of-life assessment 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
Erlotinib9

Reported measurements

baseline- global

Analysis denominator · Participants

GroupSource count
Erlotinib9
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Erlotinib64.4426.03Not reportedNot reportedNot reported
12 months- global

Analysis denominator · Participants

GroupSource count
Erlotinib2
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Erlotinib90.014.14Not reportedNot reportedNot reported
baseline- emotion

Analysis denominator · Participants

GroupSource count
Erlotinib9
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Erlotinib70.379.2Not reportedNot reportedNot reported
12 months- emotion

Analysis denominator · Participants

GroupSource count
Erlotinib2
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Erlotinib78.332.36Not reportedNot reportedNot reported
baseline- function

Analysis denominator · Participants

GroupSource count
Erlotinib9
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Erlotinib65.7812.98Not reportedNot reportedNot reported
12 months- function

Analysis denominator · Participants

GroupSource count
Erlotinib2
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Erlotinib84.05.66Not reportedNot reportedNot reported
baseline- physical

Analysis denominator · Participants

GroupSource count
Erlotinib9
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Erlotinib60.07.91Not reportedNot reportedNot reported
12 months- physical

Analysis denominator · Participants

GroupSource count
Erlotinib2
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Erlotinib73.758.84Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.03
        value
        64.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    baseline- global
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.14
        value
        90.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    12 months- global
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.2
        value
        70.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    baseline- emotion
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.36
        value
        78.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    12 months- emotion
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.98
        value
        65.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    baseline- function
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.66
        value
        84.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    12 months- function
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.91
        value
        60.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    baseline- physical
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.84
        value
        73.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    12 months- physical
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
The M.D. Anderson Dysphagia Inventory (MDADI) was used to assess effects of dysphagia on the quality of life of patients with head and neck cancer. It incorporates 3 domains (emotional, functional, and physical) as well as 1 global question. Each subscale with five possible responses scored on a scale of 1 to 5 (strongly agree, agree, no opinion, disagree and strongly disagree). Scores range from 0 (extremely low functioning) to 100 (higher functioning). Higher MDADI score represents better day-to-day functioning and better quality of life.
dispersion Type
Standard Deviation
groups
  1. description
    Erlotinib erlotinib hydrochloride pemetrexed disodium quality-of-life assessment intensity-modulated radiation therapy
    id
    OG000
    title
    Erlotinib
param Type
MEAN
population Description
Data not collected on all participants at 12 months. Data corresponds to Phase II patients.
reporting Status
POSTED
time Frame
baseline and 12 months
title
Change in Quality of Life: MDADI
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice