title: Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT02333968 December 29, 2014.
authors.affiliation: School for Public Health and Primary Care (CAPHRI), Department of Health Services Research, Maastricht University, P.O. Box 616, 6200, Maastricht, MD, The Netherlands. l.hochstenbach@maastrichtuniversity.nl.
authors.forename: Laura M J
authors.initials: LM
authors.lastname: Hochstenbach
authors.affiliation: Department of Patient and Care, Maastricht University Medical Center, P.O. Box 5800, 6202, Maastricht, AZ, The Netherlands. a.courtens@mumc.nl.
authors.forename: Annemie M
authors.initials: AM
authors.lastname: Courtens
authors.affiliation: School for Public Health and Primary Care (CAPHRI), Department of Health Services Research, Maastricht University, P.O. Box 616, 6200, Maastricht, MD, The Netherlands. s.zwakhalen@maastrichtuniversity.nl.|School of Health and Social Care, Dept. of Social Work and Health Development, University of Greenwich, Avery Hill Rd, London, SE9 2UG, UK. s.zwakhalen@maastrichtuniversity.nl.
authors.forename: Sandra M G
authors.initials: SM
authors.lastname: Zwakhalen
authors.affiliation: Department of Anesthesiology, School for Mental Health and Neuroscience (MHeNS), Maastricht University Medical Center, P.O. Box 5800, 6202, Maastricht, AZ, The Netherlands. maarten.van.kleef@mumc.nl.|Department of Anesthesiology, VU University Medical Center, P.O. Box 7057, 1007, Amsterdam, MB, The Netherlands. maarten.van.kleef@mumc.nl.
authors.forename: Maarten
authors.initials: M
authors.lastname: van Kleef
authors.affiliation: School for Public Health and Primary Care (CAPHRI), Department of Health Services Research, Maastricht University, P.O. Box 616, 6200, Maastricht, MD, The Netherlands. l.dewitte@maastrichtuniversity.nl.|Research Centre Technology in Care, Zuyd University of Applied Sciences, P.O. Box 550, 6400, Heerlen, AN, The Netherlands. l.dewitte@maastrichtuniversity.nl.
authors.forename: Luc P
authors.initials: LP
authors.lastname: de Witte
mesh_terms: D000553:Ambulatory Care / Q000191:economics / Q000379:methods*; D034201:Computers, Handheld; D006801:Humans; D063731:Mobile Applications; D009369:Neoplasms / Q000150:complications*; D010146:Pain / Q000209:etiology / Q000451:nursing*; D059408:Pain Management / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D010147:Pain Measurement; D010353:Patient Education as Topic; D011788:Quality of Life; D012107:Research Design; D012648:Self Care / Q000191:economics / Q000295:instrumentation / Q000379:methods*