Institute for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Germany.
Trials. 2010 Mar 22;11:29. doi: 10.1186/1745-6215-11-29.
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.
240 patients with diagnosed malignancy and pain > 3 days and average pain >or= 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.
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.
ClinicalTrials NCT00779597.
疼痛是癌症患者最常见和最痛苦的症状之一。对于大多数患者，如果提供适当的治疗，就可以获得足够的疼痛缓解。然而，由于制度、医疗保健专业人员和患者相关的障碍，疼痛仍然经常得不到充分治疗。患者的自我管理技能受到患者对疼痛管理的知识、活动和态度的影响。本试验方案旨在测试 SCION-PAIN 方案，这是一种多模块结构化干预措施，旨在提高有疼痛的癌症患者的自我管理能力。
240 名患有诊断性恶性肿瘤且疼痛>3 天且平均疼痛>或=3/10 的患者将参加在德国 2 所大学医院的 18 个病房进行的集群随机试验。干预病房的患者除了接受标准疼痛治疗外，还将接受 SCION-PAIN 方案，该方案包括 3 个模块：药物治疗疼痛管理、非药物治疗疼痛管理和出院管理。干预将由经过专门培训的肿瘤护士进行，包括患者教育、技能培训和咨询等方面的内容，以提高患者自我护理能力，从入院开始，然后每 3 天进行一次强化课程，并在出院后 2 至 3 天内进行一次电话随访咨询。对照组患者将接受标准护理。主要终点是出院后 7 天患者对癌症疼痛管理的相关障碍（BQII）的组间差异。次要终点是：疼痛强度和干扰、依从性、应对和 HRQoL。
该研究将确定患者在出院后是否继续使用所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具有较少的患者相关障碍和更好的癌症疼痛自我管理。
ClinicalTrials NCT00779597。
