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NCT00047008 · OUTCOME

Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer · Source last updated 2023-07-07

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 * months
Interval / dispersion
Standard Error
Time frame
Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.

What was measured

The PSS-HN is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet (this outcome measure), Public Eating, and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and one year calculated by use of area under the curve (AUC).

Analysis population: Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months.

Groups in this outcome

Standard Fractionation RT + Cisplatin

Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.

Accelerated Fractionation RT + Cisplatin

Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.

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

Analysis denominator · Participants

GroupSource count
Standard Fractionation RT + Cisplatin141
Accelerated Fractionation RT + Cisplatin140

Reported measurements

Source class 1
Values in score on a scale * months · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Standard Fractionation RT + Cisplatin53.361.99Not reportedNot reportedNot reported
Accelerated Fractionation RT + Cisplatin53.631.97Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.92
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Description
    Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.92
    p Value Comment
    Two-sided significance level = 0.05
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.99
        value
        53.36
      2. group Id
        OG001
        spread
        1.97
        value
        53.63
denoms
  1. counts
    1. group Id
      OG000
      value
      141
    2. group Id
      OG001
      value
      140
    units
    Participants
description
The PSS-HN is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet (this outcome measure), Public Eating, and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and one year calculated by use of area under the curve (AUC).
dispersion Type
Standard Error
groups
  1. description
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    id
    OG000
    title
    Standard Fractionation RT + Cisplatin
  2. description
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    id
    OG001
    title
    Accelerated Fractionation RT + Cisplatin
param Type
MEAN
population Description
Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months.
reporting Status
POSTED
time Frame
Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.
title
Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year
type
SECONDARY
unit Of Measure
score on a scale * months

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

Preserved source evidence · Not medical advice