A Pilot Feasibility Study Assessing the Role of Scheduled Sleep Intervention in Improving Fatigue in Cancer Patients After Completion of Chemotherapy for Hematological Malignancy.
Authors: Gostanian Nouneh , Bauml Joshua , Cortese Marisa , Greene Paul , Redd William , Gabrilove Janice 
Published: October 2019

Abstract
Abstract 4546

Background
Cancer related fatigue(CRF) is defined as “a distressing persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning”. CRF is felt by patients to be a generalized, mind-body sensation not relieved by a normal night's rest. It is affects 70-100% of cancer patients during and after therapy for cancer. In a recent study of hematological malignancy patients, 55% of patients had fatigue. At present, few interventions have demonstrated efficacy in decreasing the severity of CRF. In studies with healthy subjects as well as in patients with solid tumors, naps have been effective in improving functional status and subsequent sleep, with a short nap being more effective. Unfortunately, the effects of napping have not been well studied in patients with hematological malignancies.

Methods
Adult hematological malignancy patients experiencing fatigue with severity rated as 7 or greater out of 10, and who have completed cancer therapy at least 1 month prior to study entry are recruited for participation. Those enrolling in the study are advised to take a brief (<30 minute) afternoon nap. At intake, subjects completed Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FACIT-Fatigue) and the Pittsburgh Sleep Quality Index (PSQI), a measure of global sleep quality. Patients participated in weekly meetings with a staff clinician conducted either by phone or in person over the following 8 weeks. At four and eight weeks post-study entry, patients came in for physical exams, labs, and sleep and fatigue assessments. Additionally, patients kept a sleep diary that included amount of time slept, use of other fatigue relieving agents, and intervention compliance. The target sample size for the study is 34 participants; this sample size will be powered at 80% to show a one half standard deviation change from mean FACIT-Fatigue and PSQI scores.

Results
Data collection is still ongoing. To date, data collection and analyses have been completed for three subjects. The mean FACIT-Fatigue scores improved from a baseline of 40.5 to 44 at the study's conclusion. The PSQI score on average improved from a baseline of 7.5 to 6.

Conclusions
Changes in the mean fatigue scores exceed one half of one standard deviation from the mean in normative data. This suggests a clinically significant improvement, and further data collection may reveal statistical as well as clinical significance. Changes in sleep quality scores suggest improved sleep symptoms, but not at a level that would represent clinically significant change. Further data need to be acquired before making definitive conclusions; however, preliminary results are encouraging and suggest there may be significant improvement in fatigue and in sleep symptoms in hematological malignancy patients, with a simple napping intervention.
This study was funded in part by the NCI grant number K05-0254-0591.
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Disclosures:
No relevant conflicts of interest to declare.