Kwekkeboom, K. L., Abbott-Anderson, K., Cherwin, C., Roiland, R., Serlin, R. C., & Ward, S. E. (2012). Pilot randomized controlled trial of a patient-controlled cognitive-behavioral intervention for the pain, fatigue, and sleep disturbance symptom cluster in cancer. Journal of Pain and Symptom Management, 44, 810–822.

To test the effects of a psychoeducational intervention on pain, fatigue, and sleep disturbance.

Patients were randomly assigned to the intervention group or the wait-list control group. The intervention consisted of a single one-on-one training session with a research nurse, which was followed by recorded guidance that provided imagery, relaxation exercises, and nature sounds. Most exercises lasted 20 minutes and were delivered via an mp3 player. The study lasted two weeks.

• The sample was comprised of 78 patients (41% male, 59% female).
• Mean age was 60.29 years (standard deviation = 11.09 years).
• Patients had lung, prostate, colorectal, or gynecologic cancer.
• Patients were receiving chemotherapy or radiation therapy and had multiple concurrent symptoms at baseline.
• At study entry, all patients had to have fatigue, sleep disturbance, and pain scores of at least 3 on an 11-point numeric scale.
• Of the patients, 71% were taking steroids, 59% were taking opioids, and 86% were taking antiemetics.
   

• Multisite
• Outpatient
• Midwestern United States

Patients were undergoing the active antitumor treatment phase of care.

The study used a randomized, controlled trial, pre- and postintervention design.

• Selected items from various instruments, including the Brief Fatigue Inventory (BFI), Brief Pain Inventory (BPI), and Pittsburgh Sleep Quality Index (PSQI)
• Eleven-point numeric scales, to measure symptoms
• Patient diaries, which recorded use of cognitive-behavioral therapy (CBT) exercises
• Symptom cluster score, calculated by averaging the pain, fatigue, and sleep disturbance scores
• Symptom interference subscale of the MD Anderson Symptom Inventory (MDASI)

• Comparison of pre- and postintervention symptom severity scores showed a significant reduction in the severity of pain, fatigue, and sleep disturbance and symptom interference (p = 0.000).
• Symptom cluster scores and individual symptom scores declined in both the intervention and control groups.
• The reductions in symptom cluster severity (p < 0.05), pain (p < 0.01), and fatigue (p < 0.05) were significantly greater in the intervention group than in the control group; however, the effect sizes (calculated as partial eta) were extremely small (range 0.041–0.093).

The intervention demonstrated a small statistically significant effect on the symptoms of pain and fatigue and the overall symptom cluster of pain, fatigue, and sleep disturbance.

• The study had a small sample size, with less than 100 patients.   
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• The sample included baseline and group differences of import.
  • The control group had higher depression scores at baseline than did the intervention group.
  • A greater number of those in the intervention group dropped out of the study, suggesting that the intervention was not well accepted. Intention-to-treat analysis used the last value carried forward. If symptoms worsened, this would produce biased results.
• Although the intervention was called a CBT intervention, whether cognitive reframing or problem solving was a part of the intervention was unclear. The intervention appeared to have been a relaxation or imagery therapy.
• Measurement validity and reliability were questionable.
  • Authors used Z-scores to compare sleep disturbance severity, rather than actual scores; the reason for this was unclear. The actual change in Z-scores for this symptom was larger than the score changes associated with other symptoms, but the Z-score change was not statistically significant.
  • Whether average individual symptom scores were more meaningful than the total score for the cluster was unclear.  
• The intervention may be too expensive or impractical, in terms of training needs, to be feasible.

The intervention was a relaxation or imagery therapy rather than a true CBT. The intervention was associated with short-term statistically significant benefits, but the actual size of the effect was small. Findings suggested that approaches using relaxation and imagery may result in some small benefit for patients, but the effect was weak.