Hochstenbach, Laura M.J., Courtens, Annemie M., Zwakhalen, Sandra M.G., van Kleef, Maarten and de Witte, Luc P. (2015) Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol. BMC Cancer, 15:416. pp. 1-9. ISSN 1471-2407 (doi:10.1186/s12885-015-1428-1)

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Abstract

Background: Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Fragmentation of care, inadequate pain communication, and reluctance towards pain medication contribute to difficulties in optimizing outcomes. Integration of patient self-management and professional care by means of healthcare technology provides new opportunities in the outpatient setting.

Methods/Design: This study protocol outlines a two-armed multicenter randomized controlled trial that compares a technology based multicomponent self-management support intervention with care as usual and includes an effect, economic and process evaluation. Patients will be recruited consecutively via the outpatient oncology clinics and inpatient oncology wards of one academic hospital and one regional hospital in the south of the Netherlands. Irrespective of the stage of disease, patients are eligible when they are diagnosed with cancer and have uncontrolled moderate to severe cancer (treatment) related pain defined as NRS ≥ 4 for more than two weeks. Randomization (1:1) will assign patients to either the intervention or control group; patients in the intervention group receive self-management support and patients in the control group receive care as usual. The intervention will be delivered by registered nurses specialized in pain and palliative care. Important components include monitoring of pain, adverse effects and medication as well as graphical feedback, education, and nurse support. Effect measurements for both groups will be carried out with questionnaires at baseline (T0), after 4 weeks (T1) and after 12 weeks (T2). Pain intensity and quality of life are the primary outcomes. Secondary outcomes include self-efficacy, knowledge, anxiety, depression and pain medication use. The final questionnaire contains also questions for the economic evaluation that includes both cost-effectiveness and cost-utility analysis. Data for the process evaluation will be gathered continuously over the study period and focus on recruitment, reach, dose delivered and dose received.

Discussion: The proposed study will provide insight into the effectiveness of the self-management support intervention delivered by nurses to outpatients with uncontrolled cancer pain. Study findings will be used to empower patients and health professionals to improve cancer pain control.

Trial registration:
NCT02333968 December 29, 2014

Item Type:	Article
Additional Information:	[1] Acknowledgements (funding): This study was supported by a grant from the Dutch Cancer Society (UM2011-5079). IDEE Maastricht University, the Netherlands and Sananet Care BV, the Netherlands were involved in intervention development. [2] Articles in BioMed Central's journals are published under the Creative Commons Attribution license (CC-BY) to ensure implementation of open access as defined.
Uncontrolled Keywords:	cancer pain, outpatients, nursing, self-management, eHealth, study protocol, randomized controlled trial
Subjects:	R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine R Medicine > RT Nursing
Faculty / School / Research Centre / Research Group:	Faculty of Education, Health & Human Sciences
Related URLs:	Publisher
Last Modified:	14 Oct 2016 09:34
URI:	http://gala.gre.ac.uk/id/eprint/13728

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