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Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol.

ABSTRACT: 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.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.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.NCT02333968 December 29, 2014.

SUBMITTER: Hochstenbach LM

PROVIDER: S-EPMC4451734 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol.

Hochstenbach Laura M J LM Courtens Annemie M AM Zwakhalen Sandra M G SM van Kleef Maarten M de Witte Luc P LP

BMC cancer 20150519

<h4>Background</h4>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.<h4>Methods/design</h4>This study protocol outlines a two- ...[more]

PMID: 25986294

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Project description:Previous research suggests that self-management programs for people with chronic pain improve knowledge and self-efficacy but result in negligible effects on function. This study will investigate the effectiveness self-management support with pain science education and exercise on improving function for people with chronic pain in comparison to a wait-list control. A secondary objective is to determine which variables help to predict response to the intervention.This study will be an unblinded, randomized controlled trial with 110 participants comparing a 6-week program that includes self-management support, pain science education and exercise to a wait-list control. The primary outcome will be function measured by the Short Musculoskeletal Function Assessment - Dysfunction Index. Secondary outcomes will include pain intensity measured by a numeric pain rating scale, pain interference measured by the eight-item PROMIS pain interference item-bank, how much patients are bothered by functional problems measured by the Short Musculoskeletal Function Assessment - Bother Index, catastrophic thinking measured by the Pain Catastrophizing Scale, fear of movement/re-injury measured by the 11-item Tampa Scale of Kinesiophobia, sense of perceived injustice measured by the Injustice Experience Questionnaire, self-efficacy measured by the Pain Self-Efficacy Questionnaire, pain sensitivity measured by pressure pain threshold and cold sensitivity testing, fatigue measured by a numeric fatigue rating scale, pain neurophysiology knowledge measured by the Neurophysiology of Pain Questionnaire, healthcare utilization measured by number of visits to a healthcare provider, and work status. Assessments will be completed at baseline, 7 and 18 weeks. After the 18-week assessment, the groups will crossover; however, we anticipate carry-over effects with the treatment. Therefore, data from after the crossover will be used to estimate within-group changes and to determine predictors of response that are not for direct between-group comparisons. Mixed effects modelling will be used to determine between-group differences for all primary and secondary outcomes. A series of multiple regression models will be used to determine predictors of treatment response.This study has the potential to inform future self-management programming through evaluation of a self-management program that aims to improve function as the primary outcome.ClinicalTrials.gov NCT02422459 , registered on 13 April 2015.

Project description:BackgroundAtrial fibrillation (AF) is the most common arrhythmia worldwide. Despite effective treatment, it is characterized by frequent recurrences. Optimal therapeutic management of AF requires active participation and self-management from patients. Two major components of self-management are self-monitoring and sign-and-symptom management. Pulse self-palpation (PSP) is a method of self-monitoring; however, not all AF patients are capable of successfully performing PSP. Due to a lack of interventions on this topic, a nurse-led intervention for patients with AF (PSPAF intervention) was developed to foster self-monitoring and to enhance self-management through PSP. The purpose of this pilot study was to test the acceptability, feasibility, and potential effects of this intervention on the capability of patients' PSP and sign-and-symptom management. Moreover, we aimed at gathering data on the feasibility of applied research methods to aid in the design of future studies.MethodsThe pilot trial involved 20 adult patients with AF, randomized to an intervention or usual care group. At baseline and during a home visit 3-5 weeks later, we collected data using questionnaires, checklists, field notes, a mobile ECG device, and a diary. Acceptability and feasibility measures were validated through predefined cut-off points. Effect size estimates were expressed as relative risks (RR) and the number needed to treat (NNT).ResultsThe PSPAF intervention seemed feasible, but only partly acceptable. There were limitations in terms of potential effectiveness, suitability, addressing participants' willingness to implement its content in daily life, and adherence. Estimations of effect sizes suggest a large effect of the intervention on patients' PSP capability (RR = 6.0; 95% CI = [0.83, 43.3]; NNT = 2.4), but almost no effect on sign-and-symptom management (RR = 1.5; 95% CI = [0.7, 3.1]; NNT = 4.0). The feasibility of applied research methods showed minor limitations on recruitment and participant burden.ConclusionsDespite some limitations, the intervention seemed to be applicable and promising. Taking into account the suggestions and amendments we have made, we recommend conducting a full-scale trial to examine the efficacy of the PSPAF intervention.Trial registrationThis pilot study was registered in the German Clinical Trials Register at September 4, 2017 (Main ID: DRKS00012808).

Project description:BackgroundCardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed.ObjectiveIn this paper, we report on a protocol to evaluate Healing Circles-an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care.MethodsIn this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months.ResultsThe study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019.ConclusionsHealing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use.Trial registrationClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd).International registered report identifier (irrid)DERR1-10.2196/12322.

Project description:BackgroundLow back pain (LBP) is a leading cause of disability worldwide. Most patients with LBP encountered in primary care settings have nonspecific LBP, that is, pain with an unknown pathoanatomical cause. Self-management in the form of physical activity and strength and flexibility exercises along with patient education constitute the core components of the management of nonspecific LBP. However, the adherence to a self-management program is challenging for most patients, especially without feedback and reinforcement. Here we outline a protocol for the design and implementation of a decision support system (DSS), selfBACK, to be used by patients themselves to promote self-management of LBP.ObjectiveThe main objective of the selfBACK project is to improve self-management of nonspecific LBP to prevent chronicity, recurrence and pain-related disability. This is achieved by utilizing computer technology to develop personalized self-management plans based on individual patient data.MethodsThe decision support is conveyed to patients via a mobile phone app in the form of advice for self-management. Case-based reasoning (CBR), a technology that utilizes knowledge about previous cases along with data about the current patient case, is used to tailor the advice to the current patient, enabling a patient-centered intervention based on what has and has not been successful in previous patient cases. The data source for the CBR system comprises initial patient data collected by a Web-based questionnaire, weekly patient reports (eg, symptom progression), and a physical activity-detecting wristband. The effectiveness of the selfBACK DSS will be evaluated in a multinational, randomized controlled trial (RCT), targeting care-seeking patients with nonspecific LBP. A process evaluation will be carried out as an integral part of the RCT to document the implementation and patient experiences with selfBACK.ResultsThe selfBACK project was launched in January 2016 and will run until the end of 2020. The final version of the selfBACK DSS will be completed in 2018. The RCT will commence in February 2019 with pain-related disability at 3 months as the primary outcome. The trial results will be reported according to the CONSORT statement and the extended CONSORT-EHEALTH checklist. Exploitation of the results will be ongoing throughout the project period based on a business plan developed by the selfBACK consortium. Tailored digital support has been proposed as a promising approach to improve self-management of chronic disease. However, tailoring self-management advice according to the needs, motivation, symptoms, and progress of individual patients is a challenging task. Here we outline a protocol for the design and implementation of a stand-alone DSS based on the CBR technology with the potential to improve self-management of nonspecific LBP.ConclusionsThe selfBACK project will provide learning regarding the implementation and effectiveness of an app-based DSS for patients with nonspecific LBP.Registered report identifierRR1-10.2196/9379.

Dataset Information

Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol.

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Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol.

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