Systematic Light Exposure to Treat Cancer-Related Fatigue in Breast Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer-related Problem/Condition
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 194
- Locations
- 3
- Primary Endpoint
- FACIT-Fatigue Scale
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Cancer related fatigue (CRF) is a stressful and constant tiredness related to cancer and/or its treatment. CRF is the most intense during treatment and can severely interfere with activities of daily living, such as tasks that require physical strength or thinking clearly. Prevalence of CRF has been reported to be as high as 94% during chemotherapy and as high as 34% five years after completion of treatment (Rotonda et al. 2013; Minton & Stone 2008). There is currently no generally-accepted treatment for CRF. However, there is evidence to suggest that light therapy can help with CRF. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden, particularly among those in active treatment. Given the clinical impact of CRF, the goal of this project is to investigate a novel, low-cost and low-burden intervention for Breast Cancer patients using a particular kind of light treatment called systematic light exposure (sLE) to treat CRF. Two hundred forty-eight breast cancer (BC) patients undergoing adjuvant or neoadjuvant chemotherapy will be recruited from Memorial Sloan Kettering Cancer Center, and City of Hope. The light will be administered by light glasses daily throughout entire duration of chemotherapy. Outcomes will be assessed at eight timepoints during chemo, and a series of follow up assessments at 1 week, 1-month, 3-months and 6-months post-chemotherapy. 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 or prevents it from worsening during chemotherapy. Specific Aims: Aim 1: Determine if sLE prevents CRF from worsening in BC patients undergoing chemotherapy Aim 2: Determine whether sLE affects sleep, depression and circadian activity rhythms. Exploratory Aim 3: Investigate sLE normalizes circadian cortisol rhythms. Exploratory Aim 4: Examine whether the effects of sLE on fatigue are moderated/mediated by sleep quality, depression, and/or circadian rhythms.
Investigators
William H. Redd
Professor
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- •Newly diagnosed patients with stage 1 through 3a Breast Cancer scheduled to receive a 12-week, 16-week, 18-week, 20-week, or 24-week chemotherapy regimen, adjuvant, neoadjuvant, or already receiving chemotherapy.
- •MSH, COH and MSK can recruit participants schedule to go on aromatase inhibitors after treatment.
- •Currently over the age of
- •English language proficient.
- •Able to provide informed consent.
Exclusion Criteria
- •Under age 18
- •Breast cancer patients scheduled to undergo chemo regimen other than the 12-week, 18-week, 20-week, or 24-week regimen
- •Stage 3B breast cancer inflammatory or Stage 4 breast cancer
- •Pregnancy
- •Currently employed in night shift work
- •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))
- •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 (prior or current) within the past 5 years
- •Severe sleep disorders (e.g., Narcolepsy)
- •Self- reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
Outcomes
Primary Outcomes
FACIT-Fatigue Scale
Time Frame: up to 6 months
FACIT-Fatigue Scale - The FACIT-Fatigue scale will be used both for selection of patients into the study and as an outcome measure of fatigue. Smith et al. (1999) report that this 13 item scale has excellent test-retest reliability (r = 0.90) and internal consistency reliability (alpha = 0.93-0.95). In addition, criterion related validity studies using objective measures of physical function as the outcome show that patient reported fatigue based on the FACIT- Fatigue can predict these objective measures. This measure is the main tool for measuring fatigue in the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. Cella (personal communication) has indicated that a FACIT-Fatigue score equal to or less than 33 constitutes clinically significant fatigue.
Secondary Outcomes
- The Center for Epidemiological Studies Depression Scale (CES-D)(up to 6 months)
- Credibility/Expectancy Questionnaire(up to 6 months)
- Chronotype (MEQ)(up to 6 months)
- The Pittsburgh Sleep Quality Index(up to 6 months)