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Randomized Controlled Trial Comparative Study
Results of a randomized controlled pilot study of a self-management intervention for cancer pain.
- Antje Koller, Christine Miaskowski, Sabina De Geest, Oliver Opitz, and Elisabeth Spichiger.
- Institute of Nursing Science, Faculty of Medicine, University of Basel, Switzerland.
- Eur J Oncol Nurs. 2013 Jun 1;17(3):284-91.
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 NumberNCT00920504.Copyright © 2012 Elsevier Ltd. All rights reserved.
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