Cancer-related Problem/Condition, Circadian Rhythm Disorders, Depression
Conditions
Keywords
Autologous Stem Cell Transplant, Multiple Myeloma, oncology, circadian rhythms, light therapy, Hematopoietic stem cell transplantation
Brief summary
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.
Interventions
DEVICEPEI Experimental Light
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
DEVICEComparison Light
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Neither the study participant nor the research coordinator know that study condition of the patient.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Who will undergo their first autologous HSCT procedure as treatment for multiple myeloma AND: * Who are currently 21 years of age or older * English language proficient * Able to provide informed consent
Exclusion criteria
* Under age 21 * Previous HSCT procedure (autologous or allogeneic)Pregnancy * Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage) * Secondary cancer diagnosis within the last 5 years * Severe sleep disorders (e.g., Narcolepsy) * History of bipolar disorder or manic episodes (which is a contra-indication for light treatment) * Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months) * Previous use of light therapy to alleviate fatigue or depressive symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FACIT-Fatigue Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Pittsburgh Sleep Quality Index | 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. |
| SF-36 Scale | 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 |
| Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale) | 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. |
| CES-D (Center for Epidemiologic Studies Depression Scale) | 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. |
| The Positive and Negative Affect Schedule (PANAS) | 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. |
| Change in Brief Symptoms Inventory-18 (BSI-18) | 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. |
| Fatigue Line Scale | 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. |
| Multidimensional Fatigue | up to 3 months | The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Tested for its psychometric properties in cancer patients receiving radiotherapy, patients with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians, it was found to have good Test-retest Reliability (r=0.80) and great Internal Consistency (Cronbach's alpha = 0.92). |
| Sleep Latency | 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 |
| Sleep Efficiency | 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 |
| Wake Time | 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. |
| Wake Percent | Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge | Wake percent measured by actigraph - Wake percent is the average percent of each night spent awake |
| Sleep Time | Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge | Sleep time measured by actigraph. Sleep time - average number of minutes the participant was asleep 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. |
| Sleep Percent | Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge | Sleep percent measured by actigraph. Sleep percent is the percent of time spent in bed that the participant is asleep. |
| Melatonin | Baseline and Discharge | Melatonin level |
| Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) | 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. |
Countries
United States
Participant flow
Recruitment details
89 consented, but 16 not enrolled
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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. | 35 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible | 2 | 1 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Circadian Inactive Dim White Light (DWL) | Total | Circadian Active Bright White Light (BWL) |
|---|---|---|---|
| Age, Continuous | 58.58 years STANDARD_DEVIATION 7.521 | 60.04 years STANDARD_DEVIATION 8.083 | 61.18 years STANDARD_DEVIATION 8.507 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 22 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 45 Participants | 24 Participants |
| Sex: Female, Male Female | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Male | 22 Participants | 46 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 35 |
| other Total, other adverse events | 0 / 38 | 0 / 35 |
| serious Total, serious adverse events | 0 / 38 | 0 / 35 |
Outcome results
Primary
FACIT-Fatigue Scale
The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.
Time frame: Baseline, Day 2, 7, 14, 28 and 90
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | FACIT-Fatigue Scale | Baseline | 37.00 score on a scale | Standard Deviation 9.8 |
| Circadian Active Bright White Light (BWL) | FACIT-Fatigue Scale | Day 2 | 38.71 score on a scale | Standard Deviation 7.62 |
| Circadian Active Bright White Light (BWL) | FACIT-Fatigue Scale | Day 7 | 29.16 score on a scale | Standard Deviation 11.32 |
| Circadian Active Bright White Light (BWL) | FACIT-Fatigue Scale | Day 14 | 35.97 score on a scale | Standard Deviation 8.41 |
| Circadian Active Bright White Light (BWL) | FACIT-Fatigue Scale | Day 28 | 38.17 score on a scale | Standard Deviation 11.26 |
| Circadian Active Bright White Light (BWL) | FACIT-Fatigue Scale | Day 90 | 42.30 score on a scale | Standard Deviation 8.24 |
| Circadian Inactive Dim White Light (DWL) | FACIT-Fatigue Scale | Day 28 | 35.46 score on a scale | Standard Deviation 10.07 |
| Circadian Inactive Dim White Light (DWL) | FACIT-Fatigue Scale | Baseline | 35.06 score on a scale | Standard Deviation 10.51 |
| Circadian Inactive Dim White Light (DWL) | FACIT-Fatigue Scale | Day 14 | 29.94 score on a scale | Standard Deviation 13.59 |
| Circadian Inactive Dim White Light (DWL) | FACIT-Fatigue Scale | Day 2 | 35.00 score on a scale | Standard Deviation 11.32 |
| Circadian Inactive Dim White Light (DWL) | FACIT-Fatigue Scale | Day 90 | 38.86 score on a scale | Standard Deviation 9.49 |
| Circadian Inactive Dim White Light (DWL) | FACIT-Fatigue Scale | Day 7 | 26.37 score on a scale | Standard Deviation 13.49 |
Secondary
CES-D (Center for Epidemiologic Studies Depression Scale)
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.
Time frame: Baseline, Day 2, 7, 14, 28, and 90
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | baseline, prior to hospitalization | 11.00 score on a scale | Standard Deviation 8.47 |
| Circadian Active Bright White Light (BWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 2 | 12.48 score on a scale | Standard Deviation 9.64 |
| Circadian Active Bright White Light (BWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 7 | 15.13 score on a scale | Standard Deviation 9.01 |
| Circadian Active Bright White Light (BWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 14 | 14.43 score on a scale | Standard Deviation 8.78 |
| Circadian Active Bright White Light (BWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 28 | 9.75 score on a scale | Standard Deviation 9.03 |
| Circadian Active Bright White Light (BWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 90 | 8.13 score on a scale | Standard Deviation 7.41 |
| Circadian Inactive Dim White Light (DWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 28 | 10.27 score on a scale | Standard Deviation 7.94 |
| Circadian Inactive Dim White Light (DWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | baseline, prior to hospitalization | 10.94 score on a scale | Standard Deviation 8.12 |
| Circadian Inactive Dim White Light (DWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 14 | 18.58 score on a scale | Standard Deviation 10.71 |
| Circadian Inactive Dim White Light (DWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 2 | 12.48 score on a scale | Standard Deviation 9.26 |
| Circadian Inactive Dim White Light (DWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 90 | 6.95 score on a scale | Standard Deviation 7.17 |
| Circadian Inactive Dim White Light (DWL) | CES-D (Center for Epidemiologic Studies Depression Scale) | Day 7 | 17.93 score on a scale | Standard Deviation 11.16 |
Secondary
Change in Brief Symptoms Inventory-18 (BSI-18)
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.
Time frame: Baseline and Day 90
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Change in Brief Symptoms Inventory-18 (BSI-18) | Day 90 | .3280 T-score | Standard Deviation 0.48206 |
| Circadian Active Bright White Light (BWL) | Change in Brief Symptoms Inventory-18 (BSI-18) | Baseline | .6560 T-score | Standard Deviation 0.49498 |
| Circadian Inactive Dim White Light (DWL) | Change in Brief Symptoms Inventory-18 (BSI-18) | Day 90 | .3763 T-score | Standard Deviation 0.67975 |
| Circadian Inactive Dim White Light (DWL) | Change in Brief Symptoms Inventory-18 (BSI-18) | Baseline | .4714 T-score | Standard Deviation 0.61354 |
Secondary
Fatigue Line Scale
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.
Time frame: baseline, day 2, 7, and 14
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Fatigue Line Scale | Day 2 | 40.21 score on a scale | Standard Deviation 24.19 |
| Circadian Active Bright White Light (BWL) | Fatigue Line Scale | Baseline | 34.62 score on a scale | Standard Deviation 26.41 |
| Circadian Active Bright White Light (BWL) | Fatigue Line Scale | Day 7 | 55.55 score on a scale | Standard Deviation 28.45 |
| Circadian Active Bright White Light (BWL) | Fatigue Line Scale | Day 14 | 47.65 score on a scale | Standard Deviation 21.59 |
| Circadian Inactive Dim White Light (DWL) | Fatigue Line Scale | Day 14 | 44.23 score on a scale | Standard Deviation 33.22 |
| Circadian Inactive Dim White Light (DWL) | Fatigue Line Scale | Day 7 | 52.86 score on a scale | Standard Deviation 27.16 |
| Circadian Inactive Dim White Light (DWL) | Fatigue Line Scale | Baseline | 33.04 score on a scale | Standard Deviation 23.35 |
| Circadian Inactive Dim White Light (DWL) | Fatigue Line Scale | Day 2 | 33.21 score on a scale | Standard Deviation 21.14 |
Secondary
Melatonin
Melatonin level
Time frame: Baseline and Discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Melatonin | Baseline | 21.5116 ng/ml | Standard Deviation 20.83586 |
| Circadian Active Bright White Light (BWL) | Melatonin | Discharge, average 14 days | 31.6728 ng/ml | Standard Deviation 45.0476 |
| Circadian Inactive Dim White Light (DWL) | Melatonin | Baseline | 41.2025 ng/ml | Standard Deviation 64.54599 |
| Circadian Inactive Dim White Light (DWL) | Melatonin | Discharge, average 14 days | 19.0317 ng/ml | Standard Deviation 23.11714 |
Secondary
Multidimensional Fatigue
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Tested for its psychometric properties in cancer patients receiving radiotherapy, patients with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians, it was found to have good Test-retest Reliability (r=0.80) and great Internal Consistency (Cronbach's alpha = 0.92).
Time frame: up to 3 months
Population: Instrument not used and data not collected.
Secondary
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
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.
Time frame: Baseline, Day 30 after Discharge, Day 90 after Discharge
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) | Baseline | 3.1689 score on a scale | Standard Deviation 2.77373 |
| Circadian Active Bright White Light (BWL) | Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) | Day 30 after Discharge | 2.2365 score on a scale | Standard Deviation 2.02204 |
| Circadian Active Bright White Light (BWL) | Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) | Day 90 after Discharge | 2.2093 score on a scale | Standard Deviation 1.75925 |
| Circadian Inactive Dim White Light (DWL) | Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) | Baseline | 3.0368 score on a scale | Standard Deviation 2.1831 |
| Circadian Inactive Dim White Light (DWL) | Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) | Day 30 after Discharge | 2.8088 score on a scale | Standard Deviation 2.30284 |
| Circadian Inactive Dim White Light (DWL) | Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) | Day 90 after Discharge | 2.2371 score on a scale | Standard Deviation 2.65162 |
Secondary
Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
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.
Time frame: Baseline, Day 2, Day 7, and Day 14 post transplant
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale) | baseline, prior to hospitalization | 10 Participants |
| Circadian Active Bright White Light (BWL) | Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale) | Day 2 post- transplant | 9 Participants |
| Circadian Active Bright White Light (BWL) | Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale) | Day 7, post-transplant | 13 Participants |
| Circadian Active Bright White Light (BWL) | Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale) | Day 14, post transplant | 12 Participants |
| Circadian Inactive Dim White Light (DWL) | Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale) | Day 14, post transplant | 17 Participants |
| Circadian Inactive Dim White Light (DWL) | Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale) | baseline, prior to hospitalization | 11 Participants |
| Circadian Inactive Dim White Light (DWL) | Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale) | Day 7, post-transplant | 15 Participants |
| Circadian Inactive Dim White Light (DWL) | Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale) | Day 2 post- transplant | 8 Participants |
Secondary
SF-36 Scale
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
Time frame: Baseline and 30 days post hospital discharge
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Emotional Well Being Scale Baseline | 76.000 score on a scale | Standard Deviation 17.13393 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Emotional Well Being Scale Day 30 after discharge | 89.1667 score on a scale | Standard Deviation 8.61201 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | General Health Scale Baseline | 65.2778 score on a scale | Standard Deviation 22.58508 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | General Health Scale Day 30 after discharge | 63.8889 score on a scale | Standard Deviation 22.771 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Physical Functioning Scale Baseline | 66.3333 score on a scale | Standard Deviation 29.48769 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Physical Functioning Scale Day 30 after discharge | 78.3333 score on a scale | Standard Deviation 16.32993 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Limitations due to Physical Health Scale Baseline | 64.1667 score on a scale | Standard Deviation 38.19787 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Physicial Limitations Scale Day30 after discharge | 77.0833 score on a scale | Standard Deviation 25.20747 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Energy Fatigue Scale Baseline | 63.3333 score on a scale | Standard Deviation 11.77985 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Energy Fatigue Scale Day 30 after discharge | 69.7917 score on a scale | Standard Deviation 15.52048 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Pain Scale Baseline | 75.0000 score on a scale | Standard Deviation 24.54951 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Pain Scale Day 30 after discharge | 79.1667 score on a scale | Standard Deviation 20.41241 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Limitations due to Emotional Problems Baseline | 86.1111 score on a scale | Standard Deviation 29.49083 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Emotional Limitations Scale Day 30 after discharge | 83.3333 score on a scale | Standard Deviation 30.2765 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Social Functioning Scale Baseline | 82.50000 score on a scale | Standard Deviation 22.05917 |
| Circadian Active Bright White Light (BWL) | SF-36 Scale | Social Functioning Scale Day 30 after discharge | 93.75000 score on a scale | Standard Deviation 15.30931 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Social Functioning Scale Day 30 after discharge | 85.0000 score on a scale | Standard Deviation 16.29801 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Emotional Well Being Scale Baseline | 75.3846 score on a scale | Standard Deviation 19.8391 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Energy Fatigue Scale Baseline | 62.5000 score on a scale | Standard Deviation 15.72882 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Emotional Well Being Scale Day 30 after discharge | 76.0000 score on a scale | Standard Deviation 16.35543 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Limitations due to Emotional Problems Baseline | 75.0000 score on a scale | Standard Deviation 30.61862 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | General Health Scale Baseline | 52.8846 score on a scale | Standard Deviation 17.95253 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Energy Fatigue Scale Day 30 after discharge | 61.2500 score on a scale | Standard Deviation 21.378 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | General Health Scale Day 30 after discharge | 58.3333 score on a scale | Standard Deviation 27.63854 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Social Functioning Scale Baseline | 75.9615 score on a scale | Standard Deviation 19.40625 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Physical Functioning Scale Baseline | 64.4872 score on a scale | Standard Deviation 30.49275 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Pain Scale Baseline | 59.6154 score on a scale | Standard Deviation 29.8232 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Physical Functioning Scale Day 30 after discharge | 75.0000 score on a scale | Standard Deviation 23.97916 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Emotional Limitations Scale Day 30 after discharge | 78.3333 score on a scale | Standard Deviation 26.08746 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Limitations due to Physical Health Scale Baseline | 55.6923 score on a scale | Standard Deviation 30.74105 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Pain Scale Day 30 after discharge | 72.5000 score on a scale | Standard Deviation 28.50439 |
| Circadian Inactive Dim White Light (DWL) | SF-36 Scale | Physicial Limitations Scale Day30 after discharge | 77.5000 score on a scale | Standard Deviation 25.61738 |
Secondary
Sleep Efficiency
Sleep efficiency measured by actigraph - Sleep efficiency is defined as the average percentage of time in bed actually spent sleeping
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Sleep Efficiency | Day 2 | 87.3555 percentage of time | Standard Deviation 8.01844 |
| Circadian Active Bright White Light (BWL) | Sleep Efficiency | 3rd day post Engraftment | 84.5994 percentage of time | Standard Deviation 7.92472 |
| Circadian Active Bright White Light (BWL) | Sleep Efficiency | Day 7 | 86.2340 percentage of time | Standard Deviation 7.27702 |
| Circadian Active Bright White Light (BWL) | Sleep Efficiency | Discharge, average 14 days | 85.1650 percentage of time | Standard Deviation 7.88246 |
| Circadian Active Bright White Light (BWL) | Sleep Efficiency | Baseline | 88.1517 percentage of time | Standard Deviation 12.11416 |
| Circadian Inactive Dim White Light (DWL) | Sleep Efficiency | Discharge, average 14 days | 84.5600 percentage of time | Standard Deviation 12.06957 |
| Circadian Inactive Dim White Light (DWL) | Sleep Efficiency | Day 2 | 86.4504 percentage of time | Standard Deviation 10.24487 |
| Circadian Inactive Dim White Light (DWL) | Sleep Efficiency | Day 7 | 86.3233 percentage of time | Standard Deviation 9.426 |
| Circadian Inactive Dim White Light (DWL) | Sleep Efficiency | 3rd day post Engraftment | 83.0605 percentage of time | Standard Deviation 13.49365 |
| Circadian Inactive Dim White Light (DWL) | Sleep Efficiency | Baseline | 89.3481 percentage of time | Standard Deviation 6.34251 |
Secondary
Sleep Latency
Sleep latency measured by actigraph - Sleep latency is the average period of time between bed time and sleep start time
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Sleep Latency | Day 2 | 4.3000 minutes | Standard Deviation 8.90949 |
| Circadian Active Bright White Light (BWL) | Sleep Latency | 3rd day post Engraftment | 7.1875 minutes | Standard Deviation 10.88252 |
| Circadian Active Bright White Light (BWL) | Sleep Latency | Day 7 | 6.8500 minutes | Standard Deviation 6.25153 |
| Circadian Active Bright White Light (BWL) | Sleep Latency | Discharge, average 14 days | 3.1250 minutes | Standard Deviation 5.40216 |
| Circadian Active Bright White Light (BWL) | Sleep Latency | Baseline | 6.1739 minutes | Standard Deviation 7.6137 |
| Circadian Inactive Dim White Light (DWL) | Sleep Latency | Discharge, average 14 days | 6.1579 minutes | Standard Deviation 7.55912 |
| Circadian Inactive Dim White Light (DWL) | Sleep Latency | Baseline | 12.1481 minutes | Standard Deviation 23.62154 |
| Circadian Inactive Dim White Light (DWL) | Sleep Latency | Day 2 | 9.1538 minutes | Standard Deviation 14.94173 |
| Circadian Inactive Dim White Light (DWL) | Sleep Latency | Day 7 | 4.7778 minutes | Standard Deviation 6.81251 |
| Circadian Inactive Dim White Light (DWL) | Sleep Latency | 3rd day post Engraftment | 4.0909 minutes | Standard Deviation 4.92718 |
Secondary
Sleep Percent
Sleep percent measured by actigraph. Sleep percent is the percent of time spent in bed that the participant is asleep.
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Sleep Percent | Day 2 | 88.4100 percentage of time | Standard Deviation 7.51981 |
| Circadian Active Bright White Light (BWL) | Sleep Percent | 3rd day post Engraftment | 86.8181 percentage of time | Standard Deviation 6.67063 |
| Circadian Active Bright White Light (BWL) | Sleep Percent | Day 7 | 88.0265 percentage of time | Standard Deviation 7.21864 |
| Circadian Active Bright White Light (BWL) | Sleep Percent | Discharge, average 14 days | 87.3506 percentage of time | Standard Deviation 6.22923 |
| Circadian Active Bright White Light (BWL) | Sleep Percent | Baseline | 90.5335 percentage of time | Standard Deviation 11.90539 |
| Circadian Inactive Dim White Light (DWL) | Sleep Percent | Discharge, average 14 days | 86.9674 percentage of time | Standard Deviation 9.44681 |
| Circadian Inactive Dim White Light (DWL) | Sleep Percent | Baseline | 92.0426 percentage of time | Standard Deviation 6.25857 |
| Circadian Inactive Dim White Light (DWL) | Sleep Percent | Day 2 | 88.9254 percentage of time | Standard Deviation 7.82651 |
| Circadian Inactive Dim White Light (DWL) | Sleep Percent | Day 7 | 87.6411 percentage of time | Standard Deviation 9.11993 |
| Circadian Inactive Dim White Light (DWL) | Sleep Percent | 3rd day post Engraftment | 84.2027 percentage of time | Standard Deviation 13.55268 |
Secondary
Sleep Time
Sleep time measured by actigraph. Sleep time - average number of minutes the participant was asleep 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.
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Sleep Time | Day 2 | 423.3500 minutes | Standard Deviation 102.93753 |
| Circadian Active Bright White Light (BWL) | Sleep Time | 3rd day post Engraftment | 445.0000 minutes | Standard Deviation 114.9887 |
| Circadian Active Bright White Light (BWL) | Sleep Time | Day 7 | 422.9500 minutes | Standard Deviation 124.38246 |
| Circadian Active Bright White Light (BWL) | Sleep Time | Discharge, average 14 days | 442.7500 minutes | Standard Deviation 139.03261 |
| Circadian Active Bright White Light (BWL) | Sleep Time | Baseline | 396.0000 minutes | Standard Deviation 106.94731 |
| Circadian Inactive Dim White Light (DWL) | Sleep Time | Discharge, average 14 days | 429.0526 minutes | Standard Deviation 142.22223 |
| Circadian Inactive Dim White Light (DWL) | Sleep Time | Baseline | 444.2407 minutes | Standard Deviation 120.45869 |
| Circadian Inactive Dim White Light (DWL) | Sleep Time | Day 2 | 458.3077 minutes | Standard Deviation 122.00419 |
| Circadian Inactive Dim White Light (DWL) | Sleep Time | Day 7 | 469.0370 minutes | Standard Deviation 103.74839 |
| Circadian Inactive Dim White Light (DWL) | Sleep Time | 3rd day post Engraftment | 412.9545 minutes | Standard Deviation 103.99472 |
Secondary
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index consists of 19 self-rated instrument full scale from 0-21, with higher score indicating poorer sleep quality.
Time frame: Baseline, Day 30 and Day 90
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | The Pittsburgh Sleep Quality Index | Baseline | 6.03 score on a scale | Standard Deviation 3.11 |
| Circadian Active Bright White Light (BWL) | The Pittsburgh Sleep Quality Index | Day 30 after discharge | 5.79 score on a scale | Standard Deviation 3.6 |
| Circadian Active Bright White Light (BWL) | The Pittsburgh Sleep Quality Index | Day 90 after discharge | 4.80 score on a scale | Standard Deviation 3.41 |
| Circadian Inactive Dim White Light (DWL) | The Pittsburgh Sleep Quality Index | Baseline | 7.59 score on a scale | Standard Deviation 4.58 |
| Circadian Inactive Dim White Light (DWL) | The Pittsburgh Sleep Quality Index | Day 30 after discharge | 6.13 score on a scale | Standard Deviation 2.82 |
| Circadian Inactive Dim White Light (DWL) | The Pittsburgh Sleep Quality Index | Day 90 after discharge | 6.30 score on a scale | Standard Deviation 3.74 |
Secondary
The Positive and Negative Affect Schedule (PANAS)
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.
Time frame: Baseline, Day 30, Day 90
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Positive Day 90 after discharge | 3.4778 score on a scale | Standard Deviation 0.94465 |
| Circadian Active Bright White Light (BWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Negative Baseline | 1.6455 score on a scale | Standard Deviation 0.65154 |
| Circadian Active Bright White Light (BWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Negative Day 30 after discharge | 1.6524 score on a scale | Standard Deviation 0.90312 |
| Circadian Active Bright White Light (BWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Negative Day 90 after discharge | 1.4333 score on a scale | Standard Deviation 0.70875 |
| Circadian Active Bright White Light (BWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Positive Baseline | 3.2475 score on a scale | Standard Deviation 0.988 |
| Circadian Active Bright White Light (BWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Positive Day 30 after discharge | 3.3238 score on a scale | Standard Deviation 0.99242 |
| Circadian Inactive Dim White Light (DWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Positive Baseline | 3.1351 score on a scale | Standard Deviation 0.92138 |
| Circadian Inactive Dim White Light (DWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Positive Day 90 after discharge | 3.0208 score on a scale | Standard Deviation 0.89003 |
| Circadian Inactive Dim White Light (DWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Negative Day 90 after discharge | 1.5417 score on a scale | Standard Deviation 0.90068 |
| Circadian Inactive Dim White Light (DWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Negative Baseline | 1.9316 score on a scale | Standard Deviation 0.8206 |
| Circadian Inactive Dim White Light (DWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Positive Day 30 after discharge | 2.6850 score on a scale | Standard Deviation 0.96588 |
| Circadian Inactive Dim White Light (DWL) | The Positive and Negative Affect Schedule (PANAS) | PANAS Negative Day 30 after discharge | .93667 score on a scale | Standard Deviation 1.595 |
Secondary
Wake Percent
Wake percent measured by actigraph - Wake percent is the average percent of each night spent awake
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Wake Percent | Baseline | 9.4665 percentage of time | Standard Deviation 11.90539 |
| Circadian Active Bright White Light (BWL) | Wake Percent | 3rd day post Engraftment | 13.1819 percentage of time | Standard Deviation 6.67063 |
| Circadian Active Bright White Light (BWL) | Wake Percent | Day 2 | 11.5900 percentage of time | Standard Deviation 7.51981 |
| Circadian Active Bright White Light (BWL) | Wake Percent | Discharge, average 14 days | 12.6494 percentage of time | Standard Deviation 6.22923 |
| Circadian Active Bright White Light (BWL) | Wake Percent | Day 7 | 11.9765 percentage of time | Standard Deviation 7.21864 |
| Circadian Inactive Dim White Light (DWL) | Wake Percent | Discharge, average 14 days | 13.0326 percentage of time | Standard Deviation 9.44681 |
| Circadian Inactive Dim White Light (DWL) | Wake Percent | Baseline | 7.9574 percentage of time | Standard Deviation 6.25857 |
| Circadian Inactive Dim White Light (DWL) | Wake Percent | Day 7 | 12.3589 percentage of time | Standard Deviation 9.11993 |
| Circadian Inactive Dim White Light (DWL) | Wake Percent | 3rd day post Engraftment | 15.7973 percentage of time | Standard Deviation 13.55268 |
| Circadian Inactive Dim White Light (DWL) | Wake Percent | Day 2 | 11.0746 percentage of time | Standard Deviation 7.82651 |
Secondary
Wake Time
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.
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Population: Data available only for participants who completed instrument for respective study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Circadian Active Bright White Light (BWL) | Wake Time | Day 2 | 56.1000 minutes | Standard Deviation 40.07743 |
| Circadian Active Bright White Light (BWL) | Wake Time | 3rd day post Engraftment | 68.1250 minutes | Standard Deviation 35.86805 |
| Circadian Active Bright White Light (BWL) | Wake Time | Day 7 | 57.6000 minutes | Standard Deviation 42.40209 |
| Circadian Active Bright White Light (BWL) | Wake Time | Discharge, average 14 days | 62.6875 minutes | Standard Deviation 33.40802 |
| Circadian Active Bright White Light (BWL) | Wake Time | Baseline | 41.7391 minutes | Standard Deviation 50.64602 |
| Circadian Inactive Dim White Light (DWL) | Wake Time | Discharge, average 14 days | 63.3158 minutes | Standard Deviation 57.05363 |
| Circadian Inactive Dim White Light (DWL) | Wake Time | Baseline | 40.5556 minutes | Standard Deviation 37.40561 |
| Circadian Inactive Dim White Light (DWL) | Wake Time | Day 2 | 57.2308 minutes | Standard Deviation 44.75382 |
| Circadian Inactive Dim White Light (DWL) | Wake Time | Day 7 | 69.0370 minutes | Standard Deviation 57.24675 |
| Circadian Inactive Dim White Light (DWL) | Wake Time | 3rd day post Engraftment | 84.6364 minutes | Standard Deviation 88.30981 |