Yates, P., Aranda, S., Hargraves, M., Mirolo, B., Clavarino, A., McLachlan, S., . . . Skerman, H. (2005). Randomized controlled trial of an educational intervention for managing fatigue in women receiving adjuvant chemotherapy for early-stage breast cancer. Journal of Clinical Oncology, 23, 6027–6036.

An individualized psychoeducational intervention was delivered in one face-to-face session lasting 20 minutes, followed by two telephone sessions of approximately 10 minutes each. The intervention sessions were delivered at weekly intervals. Participants were also given written materials on fatigue management. The intervention focused on helping patients develop knowledge and skills to engage in self-care behaviors that may decrease fatigue, including increasing mobility/activity, effective use of available energy reserves, and management of sleep disturbances, anxiety, and psychological concerns. The intervention also addressed the predisposing, reinforcing, and enabling factors for self-care, including beliefs, attitudes, and perceptions that might facilitate or hinder a person’s motivation to perform the desired behaviors and use the skills and resources necessary to perform the behaviors and feedback provided by family or health professionals that might influence continuance or discontinuance of the behaviors. Each session was tailored to the patients’ specific needs and circumstances and was designed to target these influencing factors. Scripts and intervention protocols for both the treatment and attentional control groups were provided by the investigators. Efforts to facilitate standardization and quality control in the delivery of the interventions were described.

• The study included 109 women beginning adjuvant chemotherapy for stage I or II breast cancer. 
• Mean age was 49.4 years (range 26–70).
• Approximately 65% had completed post-high school education, and most were from relatively high socioeconomic backgrounds.
• Of the patients, 77.4% were married.
• There were no significant differences between the interventional and control groups for any other medical variables.
• All participants had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 2, and their hemoglobin levels were at least 11.6 g/mL at recruitment.

One of five outpatient chemotherapy/day treatment facilities in a major metropolitan setting

The study was a randomized, controlled trial with an attentional control group and concealment of group allocation. Randomization procedures and attentional control conditions were used explicitly.

• Investigator-Developed Instruments: Fatigue Management Behaviors, Confidence with Managing Fatigue, and numeric rating scales for fatigue
• Revised Piper Fatigue Scale (PFS) 
• Functional Assessment of Cancer Therapy-Fatigue (FACT-F)

The most commonly used self-care actions for fatigue reported at baseline were rest, hydration, relaxation, exercise, and listening to music. Use of these actions remained relatively stable over time, and there were no significant differences in usage between groups. Patients in the intervention group reported a significantly greater mean increase in the number of actions recommended by health professionals compared with patients in the control group. There were notable increases in mean fatigue levels for both groups from time one (start of second cycle of chemotherapy) to time two (immediately after completing the intervention and start of cycle three of chemotherapy), with these higher levels of fatigue persisting at time three (start of cycle four of chemotherapy or day one of radiotherapy for those participants). The increases between baseline and immediate postintervention fatigue scores were significantly greater for the control group when compared with the intervention group for worst fatigue, average fatigue, fatigue severity, fatigue interference, and FACT-F. These differences were not sustained for changes between baseline and times three or four.

The strength of the study was the inclusion of an attentional control group.

• Effects observed in the study reflected improvements on the subjective measures of fatigue experiences rather than for objective measures of fatigue management behavior. The differences may therefore simply reflect patient expectations that they would benefit from the intervention. 
• Measurement time points may have limited the detection of a difference in the fatigue experienced at times three and four.

Psychoeducational interventions were delivered by experienced oncology nurses. Costs were limited to personnel costs and the one-time costs associated with materials development.