Pilot Study to Test the Feasibility and the Efficacy of the German Language Adapted PRO-SELF© Plus Pain Control Program, an Educational Intervention Directed at Patients and Their Family Caregivers to Reduce Cancer Pain and Related Symptoms
Background: Cancer patients experience multiple symptoms throughout the different stages of
their illness, with pain as one of the most frequent. Even though effective treatment
options exist, more than 40% of all cancer pain patients do not receive adequate pain
management. For pain control, in addition to state of the art treatment by professionals,
patients and their family caregivers (FCs) have to use self care strategies on a daily
basis, a complex process that profits from targeted support by health care providers (HCPs).
In phase 1 of this study, the intervention and the study instruments have been translated,
adapted and advanced.
Aims: The purpose of this pilot study is to refine and test an advanced and adapted German
version of the PRO-SELF© Plus Pain Control Program (PCP), an educational intervention
directed at cancer pain patients and their families to enhance their pain self management
abilities, and to calculate effect sizes for the planning of a sufficiently powered
randomized controlled trial (RCT).
Methods: The advanced and adapted German version of the PRO-SELF© Plus PCP will be tested in
a pilot RCT in cancer patients with pain from bone metastasis, compared with standard care,
with effect sizes being calculated for the planning of a sufficiently powered RCT. A
qualitative sub study will explore patients' and FCs' experiences with pain management, with
the educational intervention, and their view of burden and benefit from study participation.
Intervention: The PRO-SELF© Plus PCP is based on three key strategies: (a) provision of
information, (b) skill building, and (c) nurse coaching. The 10-week educational program
comprises a structured part (teaching of pain management skills including the use of a
weekly pillbox, the use of a pain management diary and written instructions on how to
communicate with the physician about unrelieved pain) and a tailored part. The patient's
answers on questions about his knowledge of pain management serve as basis for tailoring the
teaching (academic detailing).
Data analysis: Main outcome variables will be average and worst pain as reported daily by
the patient. In order to determine effect sizes for main effect of group, main effect of
time and the group by time interaction a repeated measure longitudinal design will be used
employing a linear mixed model approach. For the qualitative part, interviews will be
analyzed using content analysis.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain)
measured daily for 10 weeks and in week 14 and 22
Elisabeth Spichiger, PhD
Institute of Nursing Science, Faculty of Medicine, University of Basel, Switzerland
Germany: Ethics Commission