Abstract
BackgroundPain 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/DesignThis 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.DiscussionThe 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 registrationNCT02333968 December 29, 2014
Highlights
Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life
The proposed study will provide insight into the effectiveness of the self-management support intervention delivered by nurses to outpatients with uncontrolled cancer pain
Considering these challenges and difficulties, together with the barriers that have been identified in the outpatient setting [3,4,5], patients need to be supported in their cancer pain self-management [6]
Summary
As actual cancer pain management is practiced at home and outpatients face difficulties in putting prescriptions into practice [2], supporting self-management appears to be a promising solution. Departments of participating centers will be visited regularly and study information as well as number of inclusion updates will be disseminated repeatedly via commonly used communication channels Shortly after they received the informed consent documents from their treating physician, patients will be called by the researcher in order to provide more information about the study and to answer questions. Study outcomes will contribute to the understanding on interventions improving cancer pain in outpatients by means of self-management support. Authors’ information LH is PhD student at the School for Public Health and Primary Care (CAPHRI), Department of Health Services Research, Maastricht University. LdW is professor of technology in care at the School for Public Health and Primary Care (CAPHRI), Department of Health Services Research, Maastricht University
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