title: Results of a randomized controlled pilot study of a self-management intervention for cancer pain.
abstract: OBJECTIVE
  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
  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.
  
  
  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.
  
  
  BACKGROUND
  NCT00920504.
authors.affiliation: Institute of Nursing Science, Faculty of Medicine, University of Basel, Switzerland.
authors.forename: Antje
authors.initials: A
authors.lastname: Koller
authors.forename: Christine
authors.initials: C
authors.lastname: Miaskowski
authors.forename: Sabina
authors.initials: S
authors.lastname: De Geest
authors.forename: Oliver
authors.initials: O
authors.lastname: Opitz
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Spichiger
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000473:pathology; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D010148:Intractable Pain / Q000188:drug therapy* / Q000209:etiology; D010349:Patient Compliance / Q000706:statistics & numerical data; D010353:Patient Education as Topic; D010865:Pilot Projects; D018570:Risk Assessment; D012648:Self Care / Q000379:methods*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid