PURPOSE OF THE RESEARCH: This 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 SAMPLE: Thirty-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 RESULTS: The 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. CONCLUSIONS: This 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.
RCT Entities:
PURPOSE OF THE RESEARCH: This 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 SAMPLE: Thirty-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 RESULTS: The 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. CONCLUSIONS: This 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.
Authors: Karen L Schumacher; Vicki L Plano Clark; Claudia M West; Marylin J Dodd; Michael W Rabow; Christine Miaskowski Journal: J Pain Symptom Manage Date: 2014-04-05 Impact factor: 3.612
Authors: Jasvinder A Singh; Daniel Satele; Suneetha Pattabasavaiah; Jan C Buckner; Jeff A Sloan Journal: Health Qual Life Outcomes Date: 2014-12-18 Impact factor: 3.186