Abstract

Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the German PRO-Self? Plus Pain Control Program originally developed in the United States. This program will be implemented into clinical practice at the Medical Center-University of Freiburg. The purpose of this multiple methods pilot study is to test the implementation regarding feasibility and effects in clinical practice. In a randomized, wait-list controlled pilot study, adult oncology in-patients of a palliative care consultation service with pain >3/10 will be recruited. The intervention will be performed by a specialized advanced practice nurse with an in-hospital visit and, after discharge, via phone calls and visits. The follow-up will be personalized according to a clinical algorithm that factors in pain intensity, satisfaction with pain management, and patient adherence. The intervention includes structured and tailored components and is based on three key strategies: information, skill building and nurse coaching. The specific aims of this study are threefold: 1) to test the feasibility of the study and intervention procedures; 2) to establish effect sizes of main outcome variables (e.g. decrease pain intensity, reduce the number of patients with pain as main symptom) for subsequent power calculation; 3) to explore participants’ experiences with pain self-management support and their view of burden and benefit from study participation in a qualitative substudy. During the study period, which includes three data collection time points (T0 before, T1 one week and T2 six weeks after discharge), data will be collected via field notes of study nurses and questionnaires of patients. The results of this pilot study will build the basis for a larger comparative effectiveness study in which long term outcomes of a cancer pain self-management intervention in clinical practice will be evaluated.

Highlights

  • Between 30% and 75% of cancer patients experience pain, depending on the type and stage of the illness [1,2]

  • More than 40% of cancer patients receive inadequate pain management

  • Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the German PRO-Self© Plus Pain Control Program originally developed in the United States

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Summary

INTRODUCTION

Between 30% and 75% of cancer patients experience pain, depending on the type and stage of the illness [1,2]. Effective treatment options exist, more than 40% of patients with cancer-related pain do not receive adequate pain management [3]. While statistically significant decreases in pain intensity are seen across studies, the effects in terms of being clinically meaningful remain in the moderate range. A. Koller et al / Open Journal of Nursing 4 (2014) 85-94 greatly in design, duration, and content, and it remains unclear which types of interventions are most effective. Clinical feasibility has not yet been the focus of research for pain self-management interventions [5,6,7,8]

Development of the Self-Management Intervention
Implications of the First Pilot Study for the Proposed Project
Aims of the Study
Design
Effects and Risks
Sample Size Calculation
Methods of Randomization
Inclusion Criteria
Exclusion Criteria
Study Procedures
Statistical Design
Qualitative Substudy
Findings
2.10. Ethical and Legal Aspects
Full Text
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