Supporting self-management of pain in cancer patients: methods and lessons learned from a randomized controlled pilot...

The purposes of this paper are to describe the methods used and the knowledge gained during a pilot study that evaluated the effects of a self-management intervention for cancer pain, as well as the adaptations that were made for a larger clinical trial.

In a randomized controlled trial, the adapted German version of the PRO-SELF(©) Plus Pain Control Program (PCP), a 10-week intervention to support self-management of pain in adult oncology outpatients and their family caregivers, was compared to attention control. Primary endpoints were average and worst pain measured at 6, 10, 14, and 22 weeks after enrollment.

A total of 39 patients (19 intervention, 20 control) were recruited over 18 months. During the study, inclusion criteria were expanded. Furthermore, the structured timing of the intervention visits was too static for a dynamic symptom like cancer pain. The intervention was expanded to include symptoms that severely impacted pain self-management including chemotherapy-induced nausea and vomiting.

Apart from the provision of information and skills building, coaching cancer patients across a complex treatment is an important function of an intervention to support pain self-management. The pilot study proved to be highly useful in order to adapt planned study procedures, to balance burden and benefit for participants, and to customize the intervention to patients' needs and abilities in order to enhance feasibility and effectiveness. Findings from this pilot study will be fully integrated in a larger randomized controlled trial.

NCT00920504.