Koller, A., Miaskowski, C., De Geest, S., Opitz, O., & Spichiger, E. (2013). Results of a randomized controlled pilot study of a self-management intervention for cancer pain. European Journal of Oncology Nursing, 17, 284–291.

To evaluate the PRO-SELF^© Plus Pain Control Program in a German population to determine effect sizes and feasibility

Participants received six visits and four phone calls from an intervention nurse, who taught them effective ways to self-manage their pain, including how to set pain goals, how to titrate prescribed analgesics, how to communicate with their physician, and how to identify management strategies to achieve their pain goals. They also received nurse coaching on their recent successes and failures, as well as individualized information about their medications during each visit and phone call.

• N = 39
• AVERAGE AGE = 59.5 years
• MALES: 51%, FEMALES: 49%
• KEY DISEASE CHARACTERISTICS: Lung, breast, and other cancers; also evaluated fatigue, cognition, anxiety, and depression

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Freiburg, Germany

• PHASE OF CARE: Active antitumor treatment

• Single-center, pilot, randomized, controlled trial

• Numerical Pain Rating Scale for primary outcome measures
• Patient pain questionnaire to evaluate patients’ knowledge of how to manage cancer pain
• For additional symptoms (e.g., fatigue, cognition, anxiety):
  • Hospital Anxiety and Depression Scale
  • German Memorial Symptom Assessment Scale
  • Fatigue assessment questionnaire
  • DemTect
  • Eastern Cooperative Oncology Group performance status
  • Self-efficacy questionnaire

Neither average nor worst pain scores demonstrated statistically significant group-by-time interaction effects between the intervention and control group over the 10-week or 22-week period. The difference in the knowledge scores between the intervention and control groups was statistically significant. A large percentage of participants did not complete the study for various reasons.

This study was the first to adapt a U.S.-developed pain intervention for a German audience. It did increase pain self-management knowledge and determine effect sizes for pain intensity scores.

• Small sample (less than 100)
• Subject withdrawals 10% or more

The nursing intervention piece of this trial can have a great effect on the participants. In the U.S. and German trials, the nursing interventions were able to have an effect on fear of addiction, fear of tolerance, physical dependence, and the patients' understanding of taking their medications on a schedule.