Barsevick, A., Beck, S. L., Dudley, W. N., Wong, B., Berger, A. M., Whitmer, K., . . . Stewart, K. (2010). Efficacy of an intervention for fatigue and sleep disturbance during cancer chemotherapy. Journal of Pain and Symptom Management, 40, 200–216.

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

One hundred fifty-three individuals receiving chemotherapy were randomized to the EASE intervention and 139 were randomized to an attention control intervention. Participants in each group received three telephone sessions taught by a specially trained oncology nurse and a separate written handbook for each assigned intervention. The EASE intervention was based on the common sense model and involved appraisal and representation of symptoms, with a focus on fatigue and sleep disturbance, including communication of individualized strategies for fatigue management and sleep enhancement. The control intervention focused on information about nutrition and a healthy diet. The primary outcomes of fatigue, sleep disturbance, and functional status were measured before chemotherapy, day 4 after first treatment (baseline), and 43 to 46 or 57 to 60 days later (follow-up), depending on the chemotherapy cycle length. Two secondary outcomes, pain and depression, were chosen for evaluation, but not targeted for the intervention, because of an increasing body of evidence linking them to fatigue.

• Two hundred seventy-six patients (83% female and 17% male) receiving chemotherapy were included.
• Mean age was 53.9 years (SD = 12.02).
• The most common cancer diagnoses were breast (55%), lung (17%), lymphoma (8%), and ovarian (6%).
• Of the patients, 90% were Caucasian, 70% were married, 42% were college educated, and 95% were treated with chemotherapy alone.

• Multi-site study conducted at two universities:  one community cancer center and one comprehensive cancer center
• Outpatient
• The intervention was delivered by nurses at Fox Chase Cancer Center, Philadephia, PA
   

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial using repeated measures and an attention control.

• Demographic and clinical information form    
• General Fatigue Scale (GFS)
• Profile of Mood States Fatigue subscale (POMS-F)
• Pittsburgh Sleep Quality Index (PSQI)
• Octagonal Basic Motionlogger Actigraph
• Morin Sleep Diary
• Brief Pain Inventory (BPI)
• POMS Depressive symptoms subscale (POMS-D)
• Symptom Checklist (SCL)
• Adapted BPI interference items (SXINT)
• Short Form 12 Health Survey (SF-12)
• Eastern Cooperative Oncology Group (ECOG) Performance Status
   

Fatigue and patient-reported sleep disturbance were moderately elevated in both groups at baseline and follow-up. Actigraphy revealed that the total sleep time was almost eight hours, and sleep efficacy was in the normal range of greater than 85% for both groups at both time points. Physical functioning was diminished and at the same level as a sample with serious illness. Mental functioning was in the normal range. The EASE intervention did not improve fatigue, reduce sleep disturbance, or prevent functional decline during chemotherapy. Both the EASE intervention group and the control group had an increase in fatigue and decline in physical functioning over time. ANOVA revealed no statistically significant group-by-time effects for fatigue, sleep disturbance, or functional status. A positive outcome in both groups was a decrease in the average number of nighttime awakenings over time. Unemployed individuals showed greater benefit from the EASE intervention and reported less pain and symptom interference.

In patients with cancer undergoing chemotherapy, the EASE intervention did not significantly improve fatigue, sleep disturbance, or physical functioning compared to the control group. Potential explanations include high variability 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.

• The ineffectiveness of EASE could be affected by the intervention dose, timing of the measures, and the large number of participants with low symptom severity.
• There was an overrepresentation of patients with breast cancer and underrepresentation of patients with lung cancer.
• Factors that may have affected the outcome included variation in populations, treatments being received, and lack of control over the severity of symptoms.

Future research directions were clearly described in the study, and practice implications included:  many individuals with multiple symptoms during chemotherapy could benefit from effective behavioral interventions conducted over time by skilled nurses. Further research could inform nurses of the most effective management methods to control symptoms.