NCT03198754 · REGISTRY CONDITION SEARCH

Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2020-08-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

FACIT-Fatigue Scale

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outcome · POSTED

Multidimensional Fatigue

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outcome · POSTED

The Pittsburgh Sleep Quality Index

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outcome · POSTED

SF-36 Scale

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outcome · POSTED

Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)

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outcome · POSTED

CES-D (Center for Epidemiologic Studies Depression Scale)

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outcome · POSTED

The Positive and Negative Affect Schedule (PANAS)

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outcome · POSTED

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

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outcome · POSTED

Fatigue Line Scale

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outcome · POSTED

Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)

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outcome · POSTED

Sleep Latency

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outcome · POSTED

Sleep Efficiency

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outcome · POSTED

Wake Time

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outcome · POSTED

Wake Percent

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outcome · POSTED

Sleep Time

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outcome · POSTED

Sleep Percent

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outcome · POSTED

Melatonin

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 21 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Ambient light fixture installed in the patient's hospital room
intervention Names
Device: PEI Experimental Light
label
PEI Experimental Light
type
EXPERIMENTAL
description
Ambient light fixture installed in the patient's hospital room
intervention Names
Device: Comparison Light
label
Comparison Light
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
PEI Experimental Light
description
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
name
PEI Experimental Light
type
DEVICE
arm Group Labels
Comparison Light
description
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
name
Comparison Light
type
DEVICE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
masking Description: Neither the study participant nor the research coordinator know that study condition of the patient.
who Masked: PARTICIPANT
CARE_PROVIDER

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 73
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.
measure
FACIT-Fatigue Scale
time Frame
Baseline, Day 2, 7, 14, 28 and 90

secondary Outcomes

description
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).
measure
Multidimensional Fatigue
time Frame
up to 3 months
description
The Pittsburgh Sleep Quality Index consists of 19 self-rated instrument full scale from 0-21, with higher score indicating poorer sleep quality.
measure
The Pittsburgh Sleep Quality Index
time Frame
Baseline, Day 30 and Day 90
description
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
measure
SF-36 Scale
time Frame
Baseline and 30 days post hospital discharge
description
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.
measure
Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
time Frame
Baseline, Day 2, Day 7, and Day 14 post transplant
description
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.
measure
CES-D (Center for Epidemiologic Studies Depression Scale)
time Frame
Baseline, Day 2, 7, 14, 28, and 90
description
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.
measure
The Positive and Negative Affect Schedule (PANAS)
time Frame
Baseline, Day 30, Day 90
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.
measure
Change in Brief Symptoms Inventory-18 (BSI-18)
time Frame
Baseline and Day 90
description
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.
measure
Fatigue Line Scale
time Frame
baseline, day 2, 7, and 14
description
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.
measure
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
time Frame
Baseline, Day 30 after Discharge, Day 90 after Discharge
description
Sleep latency measured by actigraph - Sleep latency is the average period of time between bed time and sleep start time
measure
Sleep Latency
time Frame
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
description
Sleep efficiency measured by actigraph - Sleep efficiency is defined as the average percentage of time in bed actually spent sleeping
measure
Sleep Efficiency
time Frame
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
description
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.
measure
Wake Time
time Frame
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge

Full study description

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.

Source references