Clinical trial NCT03119363: Treating Cancer-Related Fatigue Through Systematic Light Exposure (Light for Fatigue Study)
Official title: Treating Cancer-Related Fatigue Through Systematic Light Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Fatigue
Keywords: cancer-related fatigue
circadian rhythms
light therapy
systematic light exposure
cancer survivors
oncology
Multiple Myeloma
Hematopoietic stem cell transplantation
Autologous stem cell transplantation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
name: Hackensack Meridian Health
First posted: 2017-04-18
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Potentially eligible ASCT survivors will be identified by HSCT physicians and nurses at each medical center. A research assistant (RA) will be introduced to survivors who express an interest in the research. An RA will explain the study and consent those who are eligible. Once informed consent is obtained, an RA will conduct the screening interview (including the FACIT-Fatigue scale and a psychiatric and sleep disorder screening). An RA will review a checklist of inclusion and exclusion criteria. This information will also be verified by a review of participants' medical charts before participation begins. Eligible study participants will be randomly assigned condition using a block randomization table prepared by our statistician. Participants who do not meet eligibility criteria or who decline participation will be informed that they have completed their participation.
Primary purpose: TREATMENT

Brief summary: Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere with activities of daily living long after completion of medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden. This study investigates a novel low-cost/ low-burden intervention: systematic light exposure to treat CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from three medical centers. The light will be administered by a small, personal light glasses daily for 4 weeks. Outcomes will be assessed at five separate time points, including baseline and follow-up. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013).The proposed study will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among ASCT survivors; 2) focus on a distinct, homogenous patient population; 3) include only survivors who experience clinical levels of CRF; and 4) address possible psychological and biological mechanisms. This study will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces CRF.

Detailed description: The proposed multi-site randomized controlled trial (RCT) will investigate a novel intervention, systematic light exposure (sLE), to treat cancer-related fatigue (CRF) among Multiple Myeloma (MM) and Diffuse Large B-Cell Lymphoma (DLBCL) following autologous stem cell transplantation (ASCT). Cancer related fatigue (CRF) is persistent exhaustion related to cancer and/or its treatment. CRF is the most common cancer side effect and can severely interfere with activities of daily living long after completion of all medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF (including yoga, cognitive behavior therapy, hypnosis, and exercise) have also been studied; however, such interventions are costly to implement and involve significant patient burden. sLE is a low-cost, low- burden intervention that we have found to have beneficial effects for patients post-ASCT. The investigators initial randomized trial for CRF found that certain light exposure was associated with clinically significant reductions in fatigue (effect size d=0.98) More relevant to the proposed research is the preliminary investigation with sLE to treat CRF in MM and DLBCL which found that patients receiving certain sLE reported significantly less fatigue ( p=0.052). The proposed RCT will test the efficacy of sLE on CRF. It will also assess the effect of sLE on sleep, depressive symptoms, and both activity and cortisol circadian rhythms as these related processes have been hypothesized as possible mechanisms of

sLE's effects on CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from two medical centers.

The light will be administered by light glasses for 4 weeks. Outcomes will be assessed at five separate time points including baseline and follow-ups.

The researchers' preliminary research has established the feasibility of this proposal. Moreover, in the preliminary research, 75% of participants completed the preliminary trial and data from the light box compliance meters showed that participants used the light boxes 80% of the days that treatment was scheduled. A large sample of fatigued MM and DLBCL ASCT survivors has been identified. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013). It will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among cancer survivors treated with ASCT; 2) focus on a distinct, homogenous patient population (MM and DLBCL ASCT survivors); 3) include only survivors who experience clinical levels of CRF; and 4) address possible mechanisms. This RCT will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention reduces CRF.

Eligibility criteria: Inclusion Criteria:

* In remission (partial to complete remission) verified by medical records
* With a history of ASCT as treatment for hematological malignancies such as MM, DLBCL, and related diseases and who are between one month and five years post-transplant

AND:

-With a score equal to or less than 33 on the FACIT-Fatigue scale (see below)

AND:

-Who are currently over age 18 and were at least age 16 at the time of ASCT

Exclusion Criteria:

* COVID diagnoses (active COVID-19) at the time of recruitment
* Under age 18
* Pregnancy
* Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia not controlled by medication, per self-report corroborated by medical chart review (e.g., Hb\<10gm/dl) )
* Severe sleep disorders (e.g. Narcolepsy)
* Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, glaucoma that causes visual impairment, macular degeneration, blindness, pupil dilation problems or retina damage)
* Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months)
* Currently employed in night shift work
* Previous use of light therapy to alleviate fatigue or depressive symptoms
* Self-reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
* Severe Psychiatric disorders assessed by the Psychoticism-Paranoia Screener
* Secondary cancer diagnosis (prior or current) within the past 5 years
* Plans to travel across meridians during the study

To decrease sample heterogeneity (consistent with JNCI, 2013 recommendations), allogeneic-HSCT survivors will not be eligible for the study.

Primary outcomes:
measure: FACIT-Fatigue Scale
timeFrame: 4 Years
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 years
measure: Rest/activity cycles
timeFrame: 4 years
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 4 years
measure: Correlation between sLE (or "Experimental Light") and depressive changes
timeFrame: 4 years
measure: Correlation between sLE (or "Experimental Light") and circadian rhythms
timeFrame: 4 years
measure: Correlation between Experimental Light compared with Comparison Light and cortisol circadian rhythm
timeFrame: 4 years
measure: General Anxiety Disorder 7-item questionnaire (GAD-7)
timeFrame: 4 years
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 4 years
measure: Patient Assessment of Own Functioning - PAOFI
timeFrame: 4 years
measure: Multidimensional Fatigue Symptom Inventory - Short Form
timeFrame: 4 years
measure: The Beck Depression Inventory II (BDI-II)
timeFrame: 4 years
measure: Impact of Event Scale - Revised (IES-R)
timeFrame: 4 years
measure: Self Compassion Scale -SCS
timeFrame: 4 years
measure: Brief Symptom Inventory-18 (BSI-18)
timeFrame: 4 years
measure: Posttraumatic Growth Inventory - (PTGI) Short Form
timeFrame: 4 years
measure: Connor-Davidson Resilience Scale (CD-RISC-10)
timeFrame: 4 years
measure: The Social Constraints Scale (SCS)
timeFrame: 4 years
measure: C/E- Credibility/Expectancy Questionnaire
timeFrame: 4 years
measure: The Anxiety Sensitivity Index-3 - (ASI-3)
timeFrame: 4 years
measure: MEQ- SA - Morningness Eveningness Questionnaire
timeFrame: 4 years
measure: Perceive Stress Scale (PSS)
timeFrame: 4 years
measure: Social Provision Scale
timeFrame: 4 years
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: William H Redd, PhD
role: PRINCIPAL_INVESTIGATOR
References: