Systematic Approaches to Supportive Care in Prostate CA

前列腺癌支持治疗的系统方法

• 批准号: 7076834
• 负责人: Erik K Fromme
• 金额: $ 13.75万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-13 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7076834
• 关键词: clinical research; computer assisted medical decision making; computer human interaction; computer system design /evaluation; human subject; human therapy evaluation; neoplasm /cancer palliative treatment; patient care management; prostate neoplasms; quality of life; questionnaires; sign /symptom; therapy adverse effect

DESCRIPTION (provided by applicant): Symptoms are a major problem across all phases of the cancer experience. Despite the presence of effective therapies for pain and other symptoms including depression, anxiety, constipation, etc., survey data demonstrates a gap between routine cancer treatment and evidence based symptom management that leaves many patients' symptoms unrecognized and under-treated. I am applying for a K07 Career Award in order to master clinical trial and symptom assessment methodology in palliative and supportive oncology in order to discover new and best practices in the field. In line with these goals, I propose developing a computer-based system that will both acquire research-quality data from patients and support oncologists in managing their patients' symptoms. The intervention will combine systematic computer-aided symptom assessment and computer-generated printed symptom summaries for patients and oncologists accompanied by relevant recommendations from clinical practice guidelines. Extensive user testing will ensure that the summaries are maximally useful and easy-to-use. The specific aims for this proposal include determining whether oncologists using this system change their symptom assessment and symptom management practice patterns and determining whether intervention group patients have less symptom burden. I propose to pilot test the intervention in a clinical trial with a sequential group design involving 100 patients with androgen independent prostate cancer who are receiving chemotherapy. The main outcomes will be physicians' prescribing patterns for analgesic, antidepressant, and laxative medications, the number of symptoms documented in 'adverse events' logs and patients' charts, and patients' QLQ-C30 scores for pain, fatigue and global quality of life. The significance of the proposed research is that it will yield an integrated symptom assessment and clinical decision support tool and generate the validation and preliminary data necessary to justify a test of the computer-based system in a multi-center randomized controlled trial.

描述（由申请人提供）：症状是癌症体验所有阶段的主要问题。尽管存在有效的疼痛和其他症状疗法，包括抑郁症，焦虑，便秘等，但调查数据表明，常规癌症治疗与基于证据的症状管理之间存在差距，这使许多患者的症状未被识别和治疗。我正在申请K07职业奖，以掌握姑息和支持性肿瘤学的临床试验和症状评估方法，以发现该领域的新和最佳实践。根据这些目标，我建议开发一种基于计算机的系统，该系统既可以从患者那里获取研究质量数据，又将支持肿瘤学家管理患者的症状。该干预措施将结合系统的计算机辅助症状评估和计算机生成的印刷症状摘要，并伴随着临床实践指南的相关建议。大量的用户测试将确保摘要在最大有用且易于使用。该提案的具体目的包括确定使用此系统的肿瘤学家是否会改变其症状评估和症状管理实践模式，并确定干预组患者的症状负担是否较小。我建议在一项临床试验中测试干预措施，其顺序组设计涉及100例接受化学疗法的独立前列腺癌患者。主要结果将是医生的处方模式，用于止痛药，抗抑郁药和泻药药物，“不良事件”日志和患者图表中记录的症状数量以及患者'QLQ-C30的疼痛，疲劳，疲劳和全球生活质量。拟议研究的重要性是，它将产生综合症状评估和临床决策支持工具，并生成在多中心随机对照试验中证明基于计算机系统的验证和初步数据。