BIOBEHAVIORAL INTERVENTIONS FOR ORAL PAIN AND MUCOSITIS

口腔疼痛和粘膜炎是接受骨髓或外周血来源的自体干细胞移植的癌症患者非常普遍的治疗副作用。需要解决粘膜炎和疼痛的潜在机制的干预措施，同时涉及癌症护理中如此重要的家庭护理人员。本项目的主要目的是测试将米索前列醇(前列腺素E1类似物)与心理教育(系统地包括家庭护理人员)相结合的综合生物行为干预是否将减少口腔组织损伤和相关的急性口腔疼痛的严重程度，并增加对口腔护理和疼痛管理护理标准的坚持。第二个目的是分析和比较接受米索前列醇加心理教育、单用米索前列醇和常规护理的患者的选定成本(止痛药、营养支持和因粘膜炎而延长住院或再次住院)。实验设计将在埃默里大学和宾夕法尼亚大学的移植中心进行。同意的患者将被随机分配到常规护理、单独使用米索前列醇或米索前列醇加心理教育。将在移植前和移植后5个时间点收集粘膜炎、疼痛、遵守口腔护理和疼痛管理标准以及其他相关数据，直到移植后11天。这项研究应该有助于描述包括家庭照顾者在内的综合干预的有效性，并导致开发出具有成本效益的症状管理模式，使患者和家庭照顾者为家庭管理和接受复杂的医疗治疗做好准备。

Oral pain and mucositis are highly prevalent treatment side effects in cancer patients receiving autologous stem cell transplants of marrow or peripheral blood origin. Interventions are needed that address both the underlying mechanisms of mucositis and pain while simultaneously involving the family caregivers who are so important in cancer care The primary aim of this project is to test whether a comprehensive biobehavioral intervention combining misoprostol (a prostaglandin E1 analogue) with psychoeducation that systematically includes family caregivers will reduce severity of oral tissue injury and associated acute oral pain and increase adherence to oral care and pain management standards of care. The secondary aim is to analyze and compare selected costs (pain medications, nutritional support and prolonged hospital stay or readmission due to mucositis) in patients receiving misoprostol plus psychoeducation, misoprostol alone, and usual care. An experimental design will be conducted at the transplant centers of Emory University and the University of Pennsylvania. Consenting patients will be randomly assigned to usual care, misoprostol alone, or misoprostol plus psychoeducation. Mucositis, pain, adherence to oral care and pain management standards, and other relevant data will be collected prior to transplant and at five timepoints afterward until 11 days post-transplant. The study should help delineate the efficacy of a comprehensive intervention that incorporates family caregivers and lead to development of cost-effective models for managing symptoms that prepare patients and family caregivers for home management and undergoing complex medical therapies.