Despite highly effective treatment options, adequate pain control is a persistent problem in oncology patients. As cancer treatment is shifted increasingly towards the outpatient setting, patients’ self-management is vital for successful pain treatment. ANtiPain (Advanced Nursing Practice cancer pain self-management support) is a cancer pain self-management support intervention for patients with cancer that is already available and tested in a German speaking setting. So far, cancer pain self-management support interventions have only been tested in the rigorously controlled setting of a randomized controlled trial (RCT) and thus evidence for its comparative effectiveness is lacking.
With this study, we aim to evaluate the implementation of ANtiPain in view of its effectiveness in realistic clinical settings by using a cluster RCT with a stepped wedge design with embedded qualitative evaluations. The stepped wedge design involves the sequential rollout of the intervention. The units of randomization will be wards that frequently treat patients with cancer. The order in which wards receive the intervention will be determined at random. By the end of the 15-months clinical study phase, all wards will have received the intervention.
Before the implementation, patients receive standard care without structured cancer pain self-management support. After implementation, oncology patients with cancer-related pain will receive pain self-management support by trained staff nurses who follow the ANtiPain protocol. ANtiPain is based on three key strategies: Provision of information, skills building and nurse coaching. It consists of an in-hospital one-to-one session before discharge and a telephone follow up according to a structured clinical algorithm that is based on pain intensity, patient satisfaction with pain management and patient adherence with recommendations. Data will be collected on the patient level (e.g. pain intensity) and the organizational level (e.g. nurse self-rated pain management-related proficiency; implementation fidelity). Patients will be asked to complete questionnaires at inclusion (t0), as well as 2 (t1), 4 (t2) and 8 (t3) weeks after discharge either electronically or in paper format. Nurse-level data will be collected via online or paper-based questionnaires before implementation and 1 and 3 months after implementation.
To our knowledge, this is the first study to evaluate the implementation of a complex intervention to improve cancer pain self-management in view of its effectiveness. It is envisioned that this study will have impact on several levels. First, it addresses an unmet clinical need and will directly contribute to improving pain self-management among cancer patients in Austria. Second, study results will deepen our understanding of these types of complex patient interventions in the clinical practice environment. Third, such interventions not only target improving clinical care but also quality of life and finding cost-effective solutions. Further the international collaboration will help develop links between health systems in European countries as a way to share best practices and disseminate expertise and knowledge. Last but not least, such an exchange will facilitate the development of nursing and interdisciplinary research capacities that will remain in Europe to help address the growing societal healthcare needs related to an aging population, cancer as well as other chronic diseases.
For further information see http://homepage.univie.ac.at/antje.koller
This study is registered at clinicaltrials.gov.