BIOBEHAVIORAL INTERVENTIONS FOR ORAL PAIN AND MUCOSITIS

口腔疼痛和粘膜炎的生物行为干预

• 批准号: 6011523
• 负责人: DEBORAH B. MCGUIRE
• 金额: $ 46.32万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-02-01 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6011523
• 关键词: behavioral /social science research tag; behavioral medicine; bone marrow transplantation; clinical research; health care cost /financing; health education; human subject; human therapy evaluation; medical complication; neoplasm /cancer immunotherapy; oral facial pain; oral health; oral pharyngeal disorder; patient care management; prostaglandin E; self care

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.

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中非常普遍的治疗副作用。干预措施需要解决粘膜炎和疼痛的潜在机制，同时涉及在癌症护理中如此重要的家庭照顾者。该项目的主要目的是测试综合生物行为干预结合米索前列醇是否（前列腺素E1类似物）系统地包括家庭护理人员的心理教育将减轻口腔组织损伤和相关急性口腔疼痛的严重程度，提高对口腔护理和疼痛管理护理标准的依从性。次要目的是分析和比较接受米索前列醇加心理教育、单独使用米索前列醇和常规护理的患者的选定成本（止痛药、营养支持和延长住院时间或因粘膜炎再次入院）。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。康复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。粘膜炎、疼痛、口腔护理和疼痛管理标准的依从性以及其他相关数据将在移植前和移植后5个时间点收集，直至移植后11天。这项研究应有助于描述一个综合干预措施，包括家庭护理人员的疗效，并导致开发具有成本效益的模式，为管理症状，准备病人和家庭护理人员的家庭管理和接受复杂的药物治疗。