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Randomized Controlled Trial
. 2010 Aug;40(2):200-16.
doi: 10.1016/j.jpainsymman.2009.12.020. Epub 2010 Jun 18.

Efficacy of an intervention for fatigue and sleep disturbance during cancer chemotherapy

Andrea Barsevick  1 , Susan L Beck, William N Dudley, Bob Wong, Ann M Berger, Kyra Whitmer, Tracey Newhall, Susan Brown, Katie Stewart
Affiliations
Randomized Controlled Trial

Efficacy of an intervention for fatigue and sleep disturbance during cancer chemotherapy

Andrea Barsevick et al. J Pain Symptom Manage. 2010 Aug.

Abstract

Context: Multiple complex symptoms from cancer treatment can interfere with functioning.

Objectives: To evaluate the efficacy of an "energy and sleep enhancement" (EASE) intervention to relieve fatigue and sleep disturbance and improve health-related functional status.

Methods: Individuals receiving chemotherapy (CTX) were randomized to the EASE (n=153) or a control intervention (n=139). The EASE intervention included information and behavioral skills taught by an oncology nurse in three telephone sessions. The primary outcomes of fatigue, sleep disturbance, and functional status were measured before CTX, Day 4 after first treatment (baseline), and 43-46 or 57-60 days later (follow-up), depending on the CTX cycle length.

Results: The sample was primarily female (82%) and non-Hispanic white (89%), with mean age of 53.9 years. Fatigue and patient-reported sleep disturbance were elevated in both groups at baseline and follow-up. Actigraphy revealed that the total sleep time was almost eight hours, and sleep percent was greater than 85% for both groups at both time points (normal range). Physical functioning was diminished and at the same level as a sample with serious illness. Mental functioning was in normal range. A repeated-measures analysis of variance revealed no statistically significant group-by-time effects for fatigue, sleep disturbance, or functional status. Unemployed individuals showed greater benefit from the EASE intervention, reporting less pain and symptom interference.

Conclusion: Potential explanations include high variability and/or floor effect for fatigue, incorrect timing of measures, insufficient amount or dose of the intervention, and confounding effects of gender. Future research should consider screening for symptom severity and tailoring interventions.

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Figure 1
Eligibility, enrollment, and follow-up of study participants
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