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NCT00666211 · OUTCOME

Mood Disturbance

Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain · Source last updated 2012-09-06

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
9 weeks

What was measured

Patients in each arm will each have 5 measures on the Profile of Mood States-Short Form (POMS-SF): baseline + weeks 2, 4, 6, 8. The POMS-SF consists of 37 questions, querying 6 mood states (anxiety, depression, anger, confusion, fatigue, and vigor), with responses on a scale from 0 (not at all) to 4 (extremely). To generate a summary score, questions on vigor state are first recoded to reverse the scale, so that higher summary scores consistently indicate greater mood disturbance.

Groups in this outcome

Standard of Care

Standard pain control drugs.

Opioid Titration

Pain will be Monitored and Medication Titrated

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 of Care42
Opioid Titration56

Reported measurements

Baseline
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care1.480.55Not reportedNot reportedNot reported
Opioid Titration1.210.63Not reportedNot reportedNot reported
Week 2
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care1.450.63Not reportedNot reportedNot reported
Opioid Titration1.200.52Not reportedNot reportedNot reported
Week 4
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care1.370.70Not reportedNot reportedNot reported
Opioid Titration1.120.52Not reportedNot reportedNot reported
Week 6
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care1.190.64Not reportedNot reportedNot reported
Opioid Titration1.220.66Not reportedNot reportedNot reported
Week 8
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Standard of Care1.140.58Not reportedNot reportedNot reported
Opioid Titration1.320.70Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.55
        value
        1.48
      2. group Id
        OG001
        spread
        0.63
        value
        1.21
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.63
        value
        1.45
      2. group Id
        OG001
        spread
        0.52
        value
        1.20
    title
    Week 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.70
        value
        1.37
      2. group Id
        OG001
        spread
        0.52
        value
        1.12
    title
    Week 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.64
        value
        1.19
      2. group Id
        OG001
        spread
        0.66
        value
        1.22
    title
    Week 6
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.58
        value
        1.14
      2. group Id
        OG001
        spread
        0.70
        value
        1.32
    title
    Week 8
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      56
    units
    Participants
description
Patients in each arm will each have 5 measures on the Profile of Mood States-Short Form (POMS-SF): baseline + weeks 2, 4, 6, 8. The POMS-SF consists of 37 questions, querying 6 mood states (anxiety, depression, anger, confusion, fatigue, and vigor), with responses on a scale from 0 (not at all) to 4 (extremely). To generate a summary score, questions on vigor state are first recoded to reverse the scale, so that higher summary scores consistently indicate greater mood disturbance.
dispersion Type
Standard Deviation
groups
  1. description
    Standard pain control drugs.
    id
    OG000
    title
    Standard of Care
  2. description
    Pain will be Monitored and Medication Titrated
    id
    OG001
    title
    Opioid Titration
param Type
MEAN
reporting Status
POSTED
time Frame
9 weeks
title
Mood Disturbance
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice