Cancer patients are at significant risk for developing sleep disturbances and for experiencing serious pain during their disease or treatment trajectory. Therefore, studies examining possible relationships and /or interactions between these two symptoms and their impact on health outcomes are greatly needed. The purpose of this proposed pilot/feasibility study is to describe the quantity, efficiency, and distribution of sleep in oncology patients with pain problems and to explore relationships among pain, sleep, Quality of Life (QOL), and Functional Health Status (FHS) in these patients. The multidimensional Symptom Interactional Framework proposed by the Center for Research on Symptom Interactions and Health Outcomes will serve as the conceptual framework for the proposed pilot/feasibility study. The study will be descriptive-correlational in design and will be conducted in the outpatient medical oncology clinics at the Atlanta Veterans Affairs Medical Center. Because of the confounding effects of estrogen on sleep variables, the sample will include only adult male oncology patients. Subjects must have a solid tumor cancer diagnosis and at least one active opioid analgesic prescription or an average daily pain rating of > 2. Subjects must also have a Karnofsky Performance status score of > 50 and be in some phase of a chemotherapy regimen that includes either Carboplatin and Taxol or Cisplatin and Taxol. Subjects receiving radiation therapy are excluded. Both subjective and objective measures will be used. Subjective measures with established reliability and validity include the Pittsburgh Quality of Sleep Index, the Epworth Sleepiness Scale, the Brief Pain Inventory, the Quality of Life Index, the Stanford Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire, and the Sickness Impact Profile (measuring FHS). Activity and rest patterns will be objectively assessed over a seven-day period using wrist actigraphy. Subjects? perceptions of their experiences with sleep and pain will be obtained through qualitative interviews and the Pain and Sleep Diary. Data analysis will focus on examining relationships between pain and sleep using these subjective and objective measures. Relationships between these variables and QOL and FHS will also be explored through the use of descriptive and Spearman's rho statistics. With an expected sample size of 40, the study design will be sufficiently sensitive to a Spearman's rho of .43 at an alpha level of .05. The sample size will allow for 95 percent confidence intervals of +/- 0.31 SD. for continuous variables and +/- 15.5 percent for categorical variables. This detailed analysis of the activity-rest patterns of oncology patients and the possible relationships between pain and both day and nocturnal sleep-wake patterns is essential to understanding the mechanisms of poor sleep and, ultimately, to developing population-specific interventions to manage this symptom in cancer patients with pain.
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