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, 810–22.

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

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. Patients learned how CB strategies could affect symptoms and received an overview of 12 strategies and recommendations to practice. CB strategies included relaxation and imagery approaches. Patients were provided scripted recordings to use on an MP3 player and written instructions. Participants were followed for two weeks, and study assessments were completed at baseline and at two weeks. The control group received usual care. Intervention patients kept 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 study days 2 and 7 and at the end of the two-week study period. Postintervention measures of symptom severity were mailed to participants to complete and provide to clinic staff members.

• 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% receiving chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: 86% took antiemetics, 71% took steroids, and 59% took opioids; 93% were white; 74% had at least an undergraduate college education

• SITE: Multi-site
• SETTING TYPE: Outpatient
• LOCATION: Wisconsin, United States

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• 0–10 numeric scales for worst, least, and average pain over 24 hours and for current pain and fatigue, and worst sleep disturbance
• Brief Fatigue Inventory (BFI)
• Pittsburgh Sleep Quality Index (PSQI) (one item used)
• Summary scores were calculated as an average for each symptom, and cluster severity scores were calculated as the z-transformation of average of symptom summary scores.
• The MD Anderson Symptom Interference (MDASI) scores overall average were calculated across six items.
• Profiles of Mood States Short Form (POMS-SF)

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 = 0.003). Total cluster scores postintervention were lower in the intervention group (eta² = 0.052, p = 0.032). An examination of individual symptoms showed differences between the groups in pain and fatigue but not in sleep.

The use of various patient-controlled relaxation and imagery recordings appeared to have a beneficial effect in reducing pain and fatigue compared to a control group. There was no clear effect on sleep disruption.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Measurement validity/reliability questionable
• Other limitations/explanation: More study drop-outs in intervention group; short follow-up period; validity and reliability of cluster measurement methods unclear

The findings of this study suggest that patient use of relaxation and imagery instructions and recordings may improve the management of pain and fatigue during cancer treatment.