21 and older, any sex, with Cancer-related Problem/Condition or Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
FACIT-Fatigue ScalePrimary· Baseline, Day 2, 7, 14, 28 and 90
The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.
Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
37.00
± 9.80
Circadian Inactive Dim White Light (DWL)
35.06
± 10.51
Day 2
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
38.71
± 7.62
Circadian Inactive Dim White Light (DWL)
35.00
± 11.32
Day 7
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
29.16
± 11.32
Circadian Inactive Dim White Light (DWL)
26.37
± 13.49
Day 14
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
35.97
± 8.41
Circadian Inactive Dim White Light (DWL)
29.94
± 13.59
Day 28
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
38.17
± 11.26
Circadian Inactive Dim White Light (DWL)
35.46
± 10.07
Day 90
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
42.30
± 8.24
Circadian Inactive Dim White Light (DWL)
38.86
± 9.49
The Pittsburgh Sleep Quality IndexSecondary· Baseline, Day 30 and Day 90
The Pittsburgh Sleep Quality Index consists of 19 self-rated instrument full scale from 0-21, with higher score indicating poorer sleep quality.
Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
6.03
± 3.11
Circadian Inactive Dim White Light (DWL)
7.59
± 4.58
Day 30 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
5.79
± 3.60
Circadian Inactive Dim White Light (DWL)
6.13
± 2.82
Day 90 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
4.80
± 3.41
Circadian Inactive Dim White Light (DWL)
6.30
± 3.74
SF-36 ScaleSecondary· Baseline and 30 days post hospital discharge
Quality of life assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Emotional Well Being Scale Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
76.000
± 17.13393
Circadian Inactive Dim White Light (DWL)
75.3846
± 19.83910
Emotional Well Being Scale Day 30 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
89.1667
± 8.61201
Circadian Inactive Dim White Light (DWL)
76.0000
± 16.35543
General Health Scale Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
65.2778
± 22.58508
Circadian Inactive Dim White Light (DWL)
52.8846
± 17.95253
General Health Scale Day 30 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
63.8889
± 22.77100
Circadian Inactive Dim White Light (DWL)
58.3333
± 27.63854
Physical Functioning Scale Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
66.3333
± 29.48769
Circadian Inactive Dim White Light (DWL)
64.4872
± 30.49275
Physical Functioning Scale Day 30 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
78.3333
± 16.32993
Circadian Inactive Dim White Light (DWL)
75.0000
± 23.97916
Limitations due to Physical Health Scale Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
64.1667
± 38.19787
Circadian Inactive Dim White Light (DWL)
55.6923
± 30.74105
Physicial Limitations Scale Day30 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
77.0833
± 25.20747
Circadian Inactive Dim White Light (DWL)
77.5000
± 25.61738
Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)Secondary· Baseline, Day 2, Day 7, and Day 14 post transplant
Number of participants with score 16 or greater on CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.
baseline, prior to hospitalization
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
10
Circadian Inactive Dim White Light (DWL)
11
Day 2 post- transplant
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
9
Circadian Inactive Dim White Light (DWL)
8
Day 7, post-transplant
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
13
Circadian Inactive Dim White Light (DWL)
15
Day 14, post transplant
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
12
Circadian Inactive Dim White Light (DWL)
17
CES-D (Center for Epidemiologic Studies Depression Scale)Secondary· Baseline, Day 2, 7, 14, 28, and 90
CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.
baseline, prior to hospitalization
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
11.00
± 8.47
Circadian Inactive Dim White Light (DWL)
10.94
± 8.12
Day 2
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
12.48
± 9.64
Circadian Inactive Dim White Light (DWL)
12.48
± 9.26
Day 7
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
15.13
± 9.01
Circadian Inactive Dim White Light (DWL)
17.93
± 11.16
Day 14
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
14.43
± 8.78
Circadian Inactive Dim White Light (DWL)
18.58
± 10.71
Day 28
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
9.75
± 9.03
Circadian Inactive Dim White Light (DWL)
10.27
± 7.94
Day 90
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
8.13
± 7.41
Circadian Inactive Dim White Light (DWL)
6.95
± 7.17
The Positive and Negative Affect Schedule (PANAS)Secondary· Baseline, Day 30, Day 90
PANAS is a 20-item self-report measure of positive and negative affect. Each item rated on a 5-point scale of 1 (not at all) to 5 (extremely), each subscale from 1-5, full score from 1-5, with higher score indicating more symptoms. Change in PANAS at Day 30 and Day 90 as compared to baseline.
PANAS Negative Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
1.6455
± .65154
Circadian Inactive Dim White Light (DWL)
1.9316
± .82060
PANAS Negative Day 30 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
1.6524
± .90312
Circadian Inactive Dim White Light (DWL)
.93667
± 1.5950
PANAS Negative Day 90 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
1.4333
± .70875
Circadian Inactive Dim White Light (DWL)
1.5417
± .90068
PANAS Positive Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
3.2475
± .98800
Circadian Inactive Dim White Light (DWL)
3.1351
± .92138
PANAS Positive Day 30 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
3.3238
± .99242
Circadian Inactive Dim White Light (DWL)
2.6850
± .96588
PANAS Positive Day 90 after discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
3.4778
± .94465
Circadian Inactive Dim White Light (DWL)
3.0208
± .89003
Change in Brief Symptoms Inventory-18 (BSI-18)Secondary· Baseline and Day 90
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.
Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
.6560
± .49498
Circadian Inactive Dim White Light (DWL)
.4714
± .61354
Day 90
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
.3280
± .48206
Circadian Inactive Dim White Light (DWL)
.3763
± .67975
Fatigue Line ScaleSecondary· baseline, day 2, 7, and 14
Simple numeric graphic rating scale, marked on a line numbering 0-100, with higher score indicating more fatigue. Replaces the FACIT fatigue scale for daily fatigue assessment during inpatient procedures.
Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
34.62
± 26.41
Circadian Inactive Dim White Light (DWL)
33.04
± 23.35
Day 2
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
40.21
± 24.19
Circadian Inactive Dim White Light (DWL)
33.21
± 21.14
Day 7
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
55.55
± 28.45
Circadian Inactive Dim White Light (DWL)
52.86
± 27.16
Day 14
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
47.65
± 21.59
Circadian Inactive Dim White Light (DWL)
44.23
± 33.22
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)Secondary· Baseline, Day 30 after Discharge, Day 90 after Discharge
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) is a 30-item short form of the MFSI that measures five dimensions: general, physical, emotional, mental fatigue, and vigor. Each item is rated on a five-point Likert scale from 0 (not at all) to 4 (extremely). The total MFSI-SF score ranges from 0-4, with a higher score indicating a higher fatigue level.
Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
3.1689
± 2.77373
Circadian Inactive Dim White Light (DWL)
3.0368
± 2.18310
Day 30 after Discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
2.2365
± 2.02204
Circadian Inactive Dim White Light (DWL)
2.8088
± 2.30284
Day 90 after Discharge
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
2.2093
± 1.75925
Circadian Inactive Dim White Light (DWL)
2.2371
± 2.65162
Sleep LatencySecondary· Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep latency measured by actigraph - Sleep latency is the average period of time between bed time and sleep start time
Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
6.1739
± 7.61370
Circadian Inactive Dim White Light (DWL)
12.1481
± 23.62154
Day 2
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
4.3000
± 8.90949
Circadian Inactive Dim White Light (DWL)
9.1538
± 14.94173
Day 7
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
6.8500
± 6.25153
Circadian Inactive Dim White Light (DWL)
4.7778
± 6.81251
3rd day post Engraftment
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
7.1875
± 10.88252
Circadian Inactive Dim White Light (DWL)
4.0909
± 4.92718
Discharge, average 14 days
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
3.1250
± 5.40216
Circadian Inactive Dim White Light (DWL)
6.1579
± 7.55912
Sleep EfficiencySecondary· Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep efficiency measured by actigraph - Sleep efficiency is defined as the average percentage of time in bed actually spent sleeping
Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
88.1517
± 12.11416
Circadian Inactive Dim White Light (DWL)
89.3481
± 6.34251
Day 2
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
87.3555
± 8.01844
Circadian Inactive Dim White Light (DWL)
86.4504
± 10.24487
Day 7
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
86.2340
± 7.27702
Circadian Inactive Dim White Light (DWL)
86.3233
± 9.42600
3rd day post Engraftment
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
84.5994
± 7.92472
Circadian Inactive Dim White Light (DWL)
83.0605
± 13.49365
Discharge, average 14 days
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
85.1650
± 7.88246
Circadian Inactive Dim White Light (DWL)
84.5600
± 12.06957
Wake TimeSecondary· Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Wake time measured by actigraph. Wake time is the average number of minutes the participant spent awake each night during the 5 day period. Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.
Baseline
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
41.7391
± 50.64602
Circadian Inactive Dim White Light (DWL)
40.5556
± 37.40561
Day 2
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
56.1000
± 40.07743
Circadian Inactive Dim White Light (DWL)
57.2308
± 44.75382
Day 7
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
57.6000
± 42.40209
Circadian Inactive Dim White Light (DWL)
69.0370
± 57.24675
3rd day post Engraftment
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
68.1250
± 35.86805
Circadian Inactive Dim White Light (DWL)
84.6364
± 88.30981
Discharge, average 14 days
Group
Value
95% CI
Circadian Active Bright White Light (BWL)
62.6875
± 33.40802
Circadian Inactive Dim White Light (DWL)
63.3158
± 57.05363
Sponsor's own description
A sample of 60 patients scheduled for HSCT in the treatment of MM will be recruited in the weeks to months prior to their hospitalization. Light therapy incorporating ambient Programmed Environmental Illumination (PEI) will be used in patient hospital rooms (during scheduled transplant) to control cancer-related fatigue (CRF). The FDA has certified that light therapy, like that used in this study, is a low-risk intervention. When admitted to the hospital for a stem cell transplant, there will be a light fixture in the hospital room which the researchers will be testing to see how it may affect cancer related fatigue, sleep quality, and other negative side effects often seen with the transplant and subsequent treatment. The light fixture will turn on and off by itself in the morning. There are two treatment arms used in the study, each of the arms uses different light intensities. The study treatment received, i.e. which of the two lights, will be chosen by chance, like flipping a coin. There is an equal chance of being given each study treatment. Participants will not be told which study treatment they are getting until after the study is completed. Each light will be turned on from 7 AM to 10AM every day during transplantation. While in the hospital, assessment of fatigue, sleep activity, depression, circadian rhythms, and quality of life will continue through the course of hospitalization (14-21 days of treatment, to determine immediate impact of sPI), then repeat at one month and three months post-discharge follow-ups (to determine lasting effects). Outcomes will be assessed through standardized scales (e.g., FACIT-Fatigue Scale) and objective measures (e.g., actigraphy, daysimeter for light monitoring, melatonin from urine collection, blood inflammatory markers, all explained below). This trial will: 1) be the first randomized clinical trial (RCT) to investigate the effects of sPI to prevent CRF and other biopsychosocial side effects of transplant; 2) focus on a distinct, relatively homogenous patient population (MM-HSCT patients) with high prevalence of CRF; and 3) explore possible circadian rhythm mediation via melatonin analysis and blood analysis. This investigation will have major public health relevance as it will determine if an inexpensive and low patient burden intervention (sPI) is able to control fatigue associated with medical illnesses and related problems.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
Last refreshed: 11 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03198754.