TITLE:
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
AUTHORS:
Antje Koller, Monika Hasemann, Karin Jaroslawski, Sabina De Geest, Gerhild Becker
KEYWORDS:
Neoplasms; Pain; Patient Education; Pilot Randomized Controlled Trial
JOURNAL NAME:
Open Journal of Nursing,
Vol.4 No.2,
February
7,
2014
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.