Personal Patient Profile-Prostate (P4) Randomized, Multi-site Trial

个人患者概况 - 前列腺 (P4) 随机、多中心试验

• 批准号: 7149757
• 负责人: DONNA L. BERRY
• 金额: $ 47.56万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-20 至 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7149757
• 关键词: Internet; clinical research; conflict; decision making; diagnosis; experience; health education; neoplasm /cancer; physicians; preference; prostate; prostate neoplasms; satisfaction

DESCRIPTION (provided by applicant): No other disease condition with the high incidence of prostate cancer has so many alternatives with so few certainties. Localized prostate cancer (LPC) can be treated with one or more of several modalities including observation alone, surgery, cryosurgery, hormonal therapy, brachytherapy, or external beam radiation therapy. There are no completed, randomized studies of these treatment modalities. The complications of prostate cancer treatment, sexual, bladder, and bowel dysfunction cannot be easily compared between modalities. There is a growing body of evidence that men with LPC conduct the decision making process by considering their personal characteristics and factors which may be much more influential than any medical factor. A tailored, decision support system has been developed and pilot-tested to enhance men's personal factor clarification, search for information and experiences in expert consultation with physician specialists. The purpose of this randomized study is to compare decisional conflict and satisfaction in men receiving the Personal Patient Profile - Prostate (P4) and traditional patient education strategies. Sub-objectives include comparisons of decisional control shift, quality of life and resource utilization. An ethically and racially diverse sample of 498 men with localized prostate cancer who are preparing for a planned consult visit with a urologist and/or radiation oncologist in which treatment options are discussed. A multi-site trial will be conducted in geographically diverse locations in North America. The intervention will be delivered in both clinician offices or in participant's homes with broad-band Internet access.

描述（由申请人提供）：没有其他前列腺癌高发病率的疾病具有如此多的替代方案，而风险却如此之少。局部前列腺癌（LPC）可以用几种方式中的一种或多种进行治疗，包括单独观察、手术、冷冻手术、激素治疗、近距离放射治疗或外部射束放射治疗。目前还没有关于这些治疗方式的完整的随机研究。前列腺癌治疗的并发症，性功能障碍，膀胱和肠功能障碍，不能轻易地比较之间的方式。越来越多的证据表明，LPC患者通过考虑他们的个人特征和因素来进行决策过程，这些因素可能比任何医学因素都更有影响力。一个专门的决策支持系统已经开发并进行了试点测试，以加强男子的个人因素澄清，搜索信息和与医生专家进行专家咨询的经验。本随机研究的目的是比较接受个人患者档案-前列腺（P4）和传统患者教育策略的男性的决策冲突和满意度。子目标包括决策控制转移，生活质量和资源利用的比较。498例局限性前列腺癌男性患者的伦理和种族多样性样本，他们正准备与泌尿科医生和/或放射肿瘤科医生进行计划的咨询访问，讨论治疗方案。将在北美不同地理位置进行多中心试验。干预将在临床医生办公室或参与者家中提供宽带互联网接入。