Cancer-related Problem/ConditionPEINCT03198754
Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue
A study testing PEI Experimental Light and Comparison Light in people with Cancer-related Problem/Condition and Depression, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer-related Problem/Condition, Depression, Circadian Rhythm Disorders
- What is being tested?
- PEI Experimental Light and Comparison Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2016to 23 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoetic Stem Cell Transplantation for Multiple Myeloma
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.
- Being tested
- PEI Experimental Light, Comparison Light
- Keywords
- Autologous Stem Cell Transplant, Multiple Myeloma, oncology, circadian rhythms, light therapy, Hematopoietic stem cell transplantation
- Medical subject headings
- Depression, Chronobiology Disorders, Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEI Experimental LightDevice
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
Comparison LightDevice
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
| Study group | Role | What they receive |
|---|---|---|
| PEI Experimental Light | Experimental | Ambient light fixture installed in the patient's hospital room Receives: Device: PEI Experimental Light |
| Comparison Light | Active comparator | Ambient light fixture installed in the patient's hospital room Receives: Device: Comparison Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACIT-Fatigue Scale
The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.
Measured: Baseline, Day 2, 7, 14, 28 and 90
Secondary outcomes (16)
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).
Measured: up to 3 months
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.
Measured: Baseline, Day 30 and Day 90
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
Measured: Baseline and 30 days post hospital discharge
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.
Measured: Baseline, Day 2, Day 7, and Day 14 post transplant
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.
Measured: Baseline, Day 2, 7, 14, 28, and 90
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.
Measured: Baseline, Day 30, Day 90
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.
Measured: Baseline and Day 90
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.
Measured: baseline, day 2, 7, and 14
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.
Measured: Baseline, Day 30 after Discharge, Day 90 after Discharge
Sleep Latency
Sleep latency measured by actigraph - Sleep latency is the average period of time between bed time and sleep start time
Measured: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep Efficiency
Sleep efficiency measured by actigraph - Sleep efficiency is defined as the average percentage of time in bed actually spent sleeping
Measured: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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.
Measured: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Wake Percent
Wake percent measured by actigraph - Wake percent is the average percent of each night spent awake
Measured: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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.
Measured: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep Percent
Sleep percent measured by actigraph. Sleep percent is the percent of time spent in bed that the participant is asleep.
Measured: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Melatonin
Melatonin level
Measured: Baseline and Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start22 Jul 2016
- Primary completion23 Jan 2019
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William H. Redd, Icahn School of Medicine at Mount Sinai
- Investigators
- William H. Redd, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198754
- Sponsor's protocol ID
- GCO 15-2009
- Acronym
- PEI
- Status last verified
- Jul 2020
- First submitted
- 21 Jun 2017
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoetic Stem Cell Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03198754
- Acronym / sponsor ID
- PEI / GCO 15-2009
- Keywords
- Autologous Stem Cell Transplant, Multiple Myeloma, oncology, circadian rhythms, light therapy, Hematopoietic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 11 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEI Experimental Light | Experimental | Device: PEI Experimental LightAmbient light fixture installed in the patient's hospital room |
| Comparison Light | Active comparator | Device: Comparison LightAmbient light fixture installed in the patient's hospital room |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Who will undergo their first autologous HSCT procedure as treatment for multiple myeloma
- Who are currently 21 years of age or older
- English language proficient
- Able to provide informed consent
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEI Experimental LightAmbient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning. | Device | PEI Experimental Light |
| Comparison LightAmbient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning. | Device | Comparison Light |
Primary outcome
FACIT-Fatigue Scale
Time frame: 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.
16 secondary outcomes
Multidimensional Fatigue
Time frame: up to 3 months
The Pittsburgh Sleep Quality Index
Time frame: Baseline, Day 30 and Day 90
SF-36 Scale
Time frame: Baseline and 30 days post hospital discharge
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
CES-D (Center for Epidemiologic Studies Depression Scale)
Time frame: Baseline, Day 2, 7, 14, 28, and 90
The Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline, Day 30, Day 90
Change in Brief Symptoms Inventory-18 (BSI-18)
Time frame: Baseline and Day 90
Fatigue Line Scale
Time frame: baseline, day 2, 7, and 14
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
Time frame: Baseline, Day 30 after Discharge, Day 90 after Discharge
Sleep Latency
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep Efficiency
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Wake Time
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Wake Percent
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep Time
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep Percent
Time frame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Melatonin
Time frame: Baseline and Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Multiple MyelomaLink provided by the sponsor.
- FatigueLink provided by the sponsor.
- Genetic and Rare Diseases Information CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H. Redd, Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEI Experimental Light and Comparison Light in people with Cancer-related Problem/Condition and Depression, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT-Fatigue Scale (time frame: Baseline, Day 2, 7, 14, 28 and 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.