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 assess the efficacy of a cognitive-behavioral (CB) intervention for the pain, fatigue, and sleep disturbance symptom cluster

Patients were randomized to the CB group or a waitlist control group. The intervention was a single one-on-one training session with a research nurse providing information about causes of pain, fatigue, and sleep disturbance; rational about how CB strategies could affect symptoms; overview of 12 strategies; and recommendations for patients to practice. CB strategies were relaxation and imagery approaches. Patients were provided scripted recordings to use on an MP3 player and written instructions. Patients were followed for two weeks and completed study assessments at baseline and at two weeks. The control group had usual care. Patients in the intervention group were to keep a log recording each use of CB strategies, and all patients in both groups were taught to complete a daily symptom diary. Follow-up phone calls were made to both groups on the second study day, the seventh study day, and at the end of the two-week study period. Post-intervention measures of symptom severity were mailed to participants to complete and provide to clinic staff.

• N = 78
• MEAN AGE = 60.29 years (SD = 11.09 years)
• MALES: 41%, FEMALES: 59%
• KEY DISEASE CHARACTERISTICS: Lung, prostate, colorectal, and gynecologic cancers; 72% on chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: 86% on antiemetics, 71% on steroids, 59% on opioids; 93% white; 74% had at least undergraduate college education

• SITE: Multi-site 
• SETTING TYPE: Outpatient 
• LOCATION: Wisconsin

• PHASE OF CARE: Active antitumor treatment

• RCT

• 0–10 numeric scale for worst, least, and average pain over 24 hours, and pain now, fatigue, and worst sleep disturbance
• Brief Fatigue Inventory
• One item from the Pittsburgh Sleep Quality Index
• Summary scores were calculated as the average for each symptom, and cluster severity score was calculated as the z-transformation of the average of symptom summary scores.
• MD Anderson Symptom Inventory scores of overall average calculated across six items
• Profiles of Mood States short form

CB strategies were used an average of 13.65 times (SD = 6.98) during the two weeks. Patients in the control group were significantly more depressed at baseline (p = .003). Total cluster scores post-intervention were lower in the intervention group (eta² 0.052, p = .032). Examination of individual symptoms showed differences between groups in pain (P = .006) and fatigue, but not in sleep.

Use of various patient self-controlled relaxation and imagery recordings appeared to have a beneficial effect in reducing pain and fatigue compared to controls. No clear effect was seen on sleep disruption.

• Small sample (less than 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Measurement validity/reliability questionable
• Other limitations/explanation: More study dropouts in the intervention group; short follow-up period; validity and reliability of cluster measurement methods is unclear.

Findings suggest that patient use of relaxation and imagery instructions and recordings may improve management of pain and fatigue during cancer treatment.