Hematopoietic Stem Cell TransplantationNCT01873794
Treating Cancer-Related Fatigue Through Systematic Light Exposure
A study testing Bright white light and Dim red light in people with Hematopoietic Stem Cell Transplantation and Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Breast Cancer, Fatigue
- What is being tested?
- Bright white light and Dim red light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- With a history of HSCT as treatment for hematological malignancies and related diseases and who are up to 3.5 years post-transplant; OR
- Who are up to three and a half years post completion of chemotherapy OR chemotherapy and radiation for breast cancer with a curative intent;
- AND:
- With a score equal to or less than 33 on the FACIT-Fatigue scale (see below) and no pre-existing anemia (Hb<10gm/dl); or a score equal to or greater than 43 on the Cognitive Failures Questionnaire
- Who are currently over age 18 and at least age 16 at the time of HSCT or time of breast cancer treatment
Who cannot join
- Under age 18;
- Pregnancy;
- Confounding underlying medical illnesses;
- History of mania (which is a contra-indication for light treatment) or current clinical depression;
- And any other physical or psychological impairments including a sleep disorder diagnosis which would limit participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. There is currently no effective treatment for CRF. The purpose of this study is to investigate whether systematic exposure to light (from a commercially available Litebook) reduces CRF or other symptoms.
Read the detailed description
Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. In our research with cancer survivors 1 to 3 years after completion of hematopoietic stem cell transplant (HSCT), 40% of those we interviewed reported that CRF was a major obstacle to the resumption of usual activities. Despite its impact on quality of life, CRF is under-reported, under-diagnosed, and under-treated.
A variety of pharmacologic agents have been studied to treat CRF, but there is insufficient evidence to recommend their use. The most promising non-pharmacologic interventions -- exercise and cognitive-behavior therapy (CBT) -- have shown equally modest effects. The proposed study focuses on a promising new intervention for CRF, using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box. Study collaborator, Ancoli-Israel and her colleagues have successfully piloted this line of research with breast cancer patients undergoing chemotherapy.
The goal of this study will be to assess the effect of SLE on long-term HSCT and breast cancer survivors, and to determine the feasibility and acceptability of SLE as an intervention for CRF. The approach will be informed by the procedures that Ancoli-Israel and her colleagues developed for their research on SLE treatment for breast cancer chemotherapy, as well as by Redd's studies of CBT to treat adjustment disorders in survivors of HSCT. The study arms will test the efficacy of two different types of light treatment, bright white light and dim red light. Outcomes will be assessed through standardized measures of CRF, sleep quality, and quality of life.
- Conditions
- Hematopoietic Stem Cell Transplantation, Breast Cancer, Fatigue, Mild Cognitive Impairment, Light, Quality of Life
- Being tested
- Bright white light, Dim red light
- Keywords
- Fatigue, Sleep, Quality of life, Cancer, Light
- Medical subject headings
- Breast Neoplasms, Fatigue, Cognitive Dysfunction, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright white lightDevice
Also called Light Box, Litebook
Dim red lightDevice
Also called Light Box, Litebook
| Study group | Role | What they receive |
|---|---|---|
| Bright white light | Active comparator | using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box Receives: Device: Bright white light |
| Dim red light | Active comparator | using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box Receives: Device: Dim red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACIT-Fatigue Scale
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days. Measured at baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use
Measured: Baseline
FACIT-Fatigue Scale
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days.
Measured: at 4 weeks
FACIT-Fatigue Scale
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days.
Measured: at 3 months follow up
Secondary outcomes (18)
The Pittsburgh Sleep Quality Index
The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints). Baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use
Measured: Baseline
The Pittsburgh Sleep Quality Index
The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints).
Measured: at 4 weeks
The Pittsburgh Sleep Quality Index
The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints.
Measured: at 3 months follow up
SF-36 Scale
Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
Measured: Baseline
SF-36 Scale
Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
Measured: at 4 weeks
SF-36 Scale
Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
Measured: at 3 months follow up
CNS-Vital Signs
Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.
Measured: Baseline
CNS-Vital Signs
Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.
Measured: at 4 weeks
CNS-Vital Signs
Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.
Measured: at 3 months follow up
The Cognitive Failures Questionnaire
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
Measured: Baseline
The Cognitive Failures Questionnaire
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
Measured: at 4 weeks
The Cognitive Failures Questionnaire
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
Measured: at 3 months follow up
Brief Symptom Inventory-18
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Measured: Baseline
Brief Symptom Inventory-18
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Measured: at 4 weeks
Brief Symptom Inventory-18
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Measured: at 3 months follow up
Actiwatch Spectrum
Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
Measured: Baseline
Actiwatch Spectrum
Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
Measured: at 4 weeks
Actiwatch Spectrum
Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
Measured: at 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell TransplantationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, San Diego, Hackensack Meridian Health
- Responsible party
- Sponsor
- Investigators
- William H Redd, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873794
- Sponsor's protocol ID
- GCO 10-0864
- Other IDs
- 5R21CA158954, HSM#11-01032
- Status last verified
- Apr 2017
- First submitted
- 6 Jun 2013
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu LM, Amidi A, Valdimarsdottir H, Ancoli-Israel S, Liu L, Winkel G, Byrne EE, Sefair AV, Vega A, Bovbjerg K, Redd WH. The Effect of Systematic Light Exposure on Sleep in a Mixed Group of Fatigued Cancer Survivors. J Clin Sleep Med. 2018 Jan 15;14(1):31-39. doi: 10.5664/jcsm.6874.
PubMed 29198295
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Cancer-Related Fatigue Through Systematic Light Exposure
- ClinicalTrials.gov ID
- NCT01873794
- Acronym / sponsor ID
- GCO 10-0864
- Conditions
- Hematopoietic Stem Cell Transplantation, Breast Cancer, Fatigue, Mild Cognitive Impairment, Light, Quality of Life
- Keywords
- Fatigue, Sleep, Quality of life, Cancer, Light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, San Diego, Hackensack Meridian Health
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. There is currently no effective treatment for CRF. The purpose of this study is to investigate whether systematic exposure to light (from a commercially available Litebook) reduces CRF or other symptoms.
Detailed description
Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. In our research with cancer survivors 1 to 3 years after completion of hematopoietic stem cell transplant (HSCT), 40% of those we interviewed reported that CRF was a major obstacle to the resumption of usual activities. Despite its impact on quality of life, CRF is under-reported, under-diagnosed, and under-treated.
A variety of pharmacologic agents have been studied to treat CRF, but there is insufficient evidence to recommend their use. The most promising non-pharmacologic interventions -- exercise and cognitive-behavior therapy (CBT) -- have shown equally modest effects. The proposed study focuses on a promising new intervention for CRF, using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box. Study collaborator, Ancoli-Israel and her colleagues have successfully piloted this line of research with breast cancer patients undergoing chemotherapy.
The goal of this study will be to assess the effect of SLE on long-term HSCT and breast cancer survivors, and to determine the feasibility and acceptability of SLE as an intervention for CRF. The approach will be informed by the procedures that Ancoli-Israel and her colleagues developed for their research on SLE treatment for breast cancer chemotherapy, as well as by Redd's studies of CBT to treat adjustment disorders in survivors of HSCT. The study arms will test the efficacy of two different types of light treatment, bright white light and dim red light. Outcomes will be assessed through standardized measures of CRF, sleep quality, and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright white light | Active comparator | Device: Bright white lightusing systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box |
| Dim red light | Active comparator | Device: Dim red lightusing systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- With a history of HSCT as treatment for hematological malignancies and related diseases and who are up to 3.5 years post-transplant; OR
- Who are up to three and a half years post completion of chemotherapy OR chemotherapy and radiation for breast cancer with a curative intent;
- With a score equal to or less than 33 on the FACIT-Fatigue scale (see below) and no pre-existing anemia (Hb<10gm/dl); or a score equal to or greater than 43 on the Cognitive Failures Questionnaire
- Who are currently over age 18 and at least age 16 at the time of HSCT or time of breast cancer treatment
Key exclusion criteria (5 listed)
- Under age 18;
- Pregnancy;
- Confounding underlying medical illnesses;
- History of mania (which is a contra-indication for light treatment) or current clinical depression;
- And any other physical or psychological impairments including a sleep disorder diagnosis which would limit participation.
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 |
|---|---|---|
| Bright white lightAlso: Light Box, Litebook | Device | Bright white light |
| Dim red lightAlso: Light Box, Litebook | Device | Dim red light |
Primary outcome
FACIT-Fatigue Scale
Time frame: Baseline
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days. Measured at baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use
FACIT-Fatigue Scale
Time frame: at 4 weeks
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days.
FACIT-Fatigue Scale
Time frame: at 3 months follow up
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days.
18 secondary outcomes
The Pittsburgh Sleep Quality Index
Time frame: Baseline
The Pittsburgh Sleep Quality Index
Time frame: at 4 weeks
The Pittsburgh Sleep Quality Index
Time frame: at 3 months follow up
SF-36 Scale
Time frame: Baseline
SF-36 Scale
Time frame: at 4 weeks
SF-36 Scale
Time frame: at 3 months follow up
CNS-Vital Signs
Time frame: Baseline
CNS-Vital Signs
Time frame: at 4 weeks
CNS-Vital Signs
Time frame: at 3 months follow up
The Cognitive Failures Questionnaire
Time frame: Baseline
The Cognitive Failures Questionnaire
Time frame: at 4 weeks
The Cognitive Failures Questionnaire
Time frame: at 3 months follow up
Brief Symptom Inventory-18
Time frame: Baseline
Brief Symptom Inventory-18
Time frame: at 4 weeks
Brief Symptom Inventory-18
Time frame: at 3 months follow up
Actiwatch Spectrum
Time frame: Baseline
Actiwatch Spectrum
Time frame: at 4 weeks
Actiwatch Spectrum
Time frame: at 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Derived from this study: PubMed 29198295Wu LM, Amidi A, Valdimarsdottir H, Ancoli-Israel S, Liu L, Winkel G, Byrne EE, Sefair AV, Vega A, Bovbjerg K, Redd WH. The Effect of Systematic Light Exposure on Sleep in a Mixed Group of Fatigued Cancer Survivors. J Clin Sleep Med. 2018 Jan 15;14(1):31-39. doi: 10.5664/jcsm.6874.
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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, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright white light and Dim red light in people with Hematopoietic Stem Cell Transplantation and Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites 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 6 inclusion and 5 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01873794, which also lists 1 linked publication.
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 Apr 2017.