Testing the feasibility and effects of a self-management support intervention for patients with cancer and their family caregivers to reduce pain and related symptoms (ANtiPain): Study protocol of a pilot study

摘要

Despite effective treatment options, more than 40%of cancer patients receive inadequate pain management.Our previous pilot study resulted in substantialadaptations of a cancer pain self-management intervention,the German PRO-Self© Plus Pain ControlProgram originally developed in the United States.This program will be implemented into clinical practiceat the Medical Center-University of Freiburg.The purpose of this multiple methods pilot study is totest the implementation regarding feasibility and effectsin clinical practice. In a randomized, wait-listcontrolled pilot study, adult oncology in-patients of apalliative care consultation service with pain >3/10will be recruited. The intervention will be performedby a specialized advanced practice nurse with an inhospitalvisit and, after discharge, via phone calls andvisits. The follow-up will be personalized according toa clinical algorithm that factors in pain intensity, satisfactionwith pain management, and patient adherence.The intervention includes structured and tailoredcomponents and is based on three key strategies:information, skill building and nurse coaching. Thespecific aims of this study are threefold: 1) to test thefeasibility of the study and intervention procedures; 2)to establish effect sizes of main outcome variables (e.g.decrease pain intensity, reduce the number of patientswith pain as main symptom) for subsequentpower calculation; 3) to explore participants’ experienceswith pain self-management support and theirview of burden and benefit from study participationin a qualitative substudy. During the study period,which includes three data collection time points (T0before, T1 one week and T2 six weeks after discharge),data will be collected via field notes of studynurses and questionnaires of patients. The results ofthis pilot study will build the basis for a larger comparativeeffectiveness study in which long term outcomesof a cancer pain self-management interventionin clinical practice will be evaluated.