Results of a randomized controlled pilot study of a self-management intervention for cancer pain

Abstract

Purpose of the researchThis paper reports findings from a randomized controlled pilot study evaluating the PRO-SELF© Plus Pain Control Program, a U.S.-developed cancer pain self-management intervention, regarding feasibility and effect sizes in a German patient sample. Methods and sampleThirty-nine German oncology outpatients were randomized to intervention (n = 19) and control (n = 20) groups. The intervention group received the PRO-SELF© Plus Pain Control Program in 6 visits and 4 phone calls a 10-week period. The control group received standard education and care. The intervention employed three key strategies: information provision, skills building, and nurse coaching. Primary outcomes were changes in average and worst pain intensity. Secondary outcomes included changes in pain-related knowledge, opioid intake, and self-efficacy. Data were collected at enrollment, then at 6, 10, 14, and 22 weeks. Key resultsThe group-by-time effect showed a statistically significant increase in knowledge (week 10: p = 0.04; week 22: p < 0.01). Despite slight reductions in average and worst pain, no statistically significant changes were found for pain, opioid intake, or self-efficacy. ConclusionsThis study is the first to evaluate and demonstrate the feasibility of a U.S.-developed cancer pain self-management intervention in a German patient population. Pain self-management related knowledge improved significantly and effect sizes for pain reduction were determined. Findings from this pilot RCT provide the basis for planning a larger RCT.Clinical trial registration number: NCT00920504.