Advanced Cancers Clinical Trial
Official title:
The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer
Verified date | March 2019 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this research study is to learn if a type of light therapy can be used to help patients with advanced cancer who are having difficulty sleeping to sleep better.
Status | Terminated |
Enrollment | 12 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Advanced cancer patients seen in Supportive Care outpatient clinic at M.D. Anderson Cancer Center, with average sleep disturbance >=4 out of 10 for at least one week 2. Age 18 or greater 3. Karnofsky performance status score of >=40 at time of inclusion into study 4. Agrees to return to MD Anderson Cancer Center (MDACC) for follow-up visits 5. English speaking Exclusion Criteria: 1. Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception 2. Patients with a history of retinal disease 3. Patients with a current diagnosis of major depression disorder or generalized anxiety disorder 4. Patients who have received light therapy in the past either as part of treatment for other disorders or as a study subject 5. Patients currently on amiodarone, thiazide diuretics or epidermal growth factor receptor (EGFR) inhibitors (erlotinib, gefitinib, cetuximab, panitumumab) 6. Patients who are currently receiving ultraviolet A light/ultraviolet B light (UVA/UVB) therapy or tanning sessions at salons 7. Patients with a diagnosis of obstructive sleep apnea or narcolepsy 8. Patients with >2 hours of direct exposure to outdoor natural light per day (light exposure diary -- screening). |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of Bright Light Therapy on Sleep Disturbances Compared to Dim Red Light in Patients With Advanced Cancer Followed at a Palliative Care Outpatient Clinic at a Comprehensive Cancer Center | Pittsburgh Sleep Quality Index (PSQI) measured at baseline and two weeks. The PSQI is a validated tool for insomnia, an effective instrument for measuring the quality and patterns of sleep using a 19-item questionnaire. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. Each area is rated from 0-3 with the higher score reflecting more severe sleep complaints. The addition of all scores permits the analysis of the participant's overall sleep experience. The PSQI global score ranges from 0 to 21, with a score of 5 or greater indicating significant sleep disturbance. | Baseline and Day 14 |
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