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Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

机译:通过跨机构模块化护理干预措施改善肿瘤患者的疼痛相关自我管理:一项集群随机多中心试验的方案

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Background Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN program, a multi modular structured intervention to improve self management in cancer patients with pain. Methods 240 patients with diagnosed malignancy and pain > 3 days and average pain ≥ 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients from the intervention wards will receive, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, nonpharmacologic pain management and discharge management. The intervention will be conducted by specially trained oncology nurses and includes components of patient education, skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group will receive standard care. Primary endpoint is the group difference in patient related barriers to management of cancer pain (BQII), 7 days after discharge. Secondary endpoints are: pain intensity & interference, adherence, coping and HRQoL. Discussion The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital. It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain. Trial Registration ClinicalTrials NCT00779597
机译:背景疼痛是癌症患者中最常见,最令人困扰的症状之一。对于大多数患者,如果提供适当的治疗,则可以获得足够的疼痛缓解。然而,由于机构,医疗保健专业人员和患者相关的障碍,疼痛常常仍然得不到充分的治疗。患者的自我管理技能受患者知识,活动和对疼痛管理态度的影响。该试验方案旨在测试SCION-PAIN程序,该程序是一种多模块结构的干预措施,旨在改善患有癌症的癌症患者的自我管理。方法240例诊断为恶性且疼痛> 3天且平均疼痛≥3/1​​0的患者将参加德国2家大学医院18个病房的整群随机试验。来自干预病房的患者除接受标准的疼痛治疗外,还将接受SCION-PAIN计划,该计划包括3个模块:药理性疼痛管理,非药理性疼痛管理和出院管理。干预将由经过专门培训的肿瘤科护士进行,包括患者教育,技能培训和咨询的组成部分,以改善关于疼痛管理的自我护理,从入院开始,每3天进行一次强化治疗,并在术后2至3天进行一次电话随访卸货。对照组的患者将接受标准护理。主要终点是出院后7天患者相关的癌症疼痛控制障碍(BQII)的群体差异。次要终点是:疼痛强度和干扰,依从性,应对和HRQoL。讨论该研究将确定出院后是否继续使用患者获得的自我管理技能。假设接受多模块结构化干预的患者将减少与患者相关的障碍,并更好地自我管理癌症疼痛。试验注册临床试验NCT00779597

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