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NCT03198754 · OUTCOME

Change in Brief Symptoms Inventory-18 (BSI-18)

Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue · Source last updated 2020-08-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
T-score
Interval / dispersion
Standard Deviation
Time frame
Baseline and Day 90

What was measured

Brief Symptom Inventory-18 (BSI-18) - self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.

Analysis population: Thirty-eight participants were randomized to the bright white light condition (BWL) and 35 were randomized to the dim white light condition (DWL). Not all participants completed each measure at all time-points. For intent to treat analyses all participants need to be accounted for.

Groups in this outcome

Circadian Active Bright White Light (BWL)

PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.

Circadian Inactive Dim White Light (DWL)

Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.

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

Analysis denominator · Participants

GroupSource count
Circadian Active Bright White Light (BWL)38
Circadian Inactive Dim White Light (DWL)35

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Circadian Active Bright White Light (BWL)16
Circadian Inactive Dim White Light (DWL)17
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Circadian Active Bright White Light (BWL).6560.49498Not reportedNot reportedNot reported
Circadian Inactive Dim White Light (DWL).4714.61354Not reportedNot reportedNot reported
Day 90

Analysis denominator · Participants

GroupSource count
Circadian Active Bright White Light (BWL)21
Circadian Inactive Dim White Light (DWL)22
Values in T-score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Circadian Active Bright White Light (BWL).3280.48206Not reportedNot reportedNot reported
Circadian Inactive Dim White Light (DWL).3763.67975Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        .49498
        value
        .6560
      2. group Id
        OG001
        spread
        .61354
        value
        .4714
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        .48206
        value
        .3280
      2. group Id
        OG001
        spread
        .67975
        value
        .3763
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Day 90
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      35
    units
    Participants
description
Brief Symptom Inventory-18 (BSI-18) - self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.
dispersion Type
Standard Deviation
groups
  1. description
    PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
    id
    OG000
    title
    Circadian Active Bright White Light (BWL)
  2. description
    Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
    id
    OG001
    title
    Circadian Inactive Dim White Light (DWL)
param Type
MEAN
population Description
Thirty-eight participants were randomized to the bright white light condition (BWL) and 35 were randomized to the dim white light condition (DWL). Not all participants completed each measure at all time-points. For intent to treat analyses all participants need to be accounted for.
reporting Status
POSTED
time Frame
Baseline and Day 90
title
Change in Brief Symptoms Inventory-18 (BSI-18)
type
SECONDARY
unit Of Measure
T-score

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

Preserved source evidence · Not medical advice