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 receivingchemotherapy (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. Copyright (c) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
RCT Entities:
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. Copyright (c) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
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