Trials / Completed
CompletedNCT01873794
Treating Cancer-Related Fatigue Through Systematic Light Exposure
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
- Hematopoietic Stem Cell Transplantation
- Breast Cancer
- Fatigue
- Mild Cognitive Impairment
- Light
- Quality of Life
- Sleep
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bright white light | |
| DEVICE | Dim red light |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2013-06-10
- Last updated
- 2017-04-11
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01873794. Inclusion in this directory is not an endorsement.