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: 7637378
• 负责人: Seth Wolpin
• 金额: $ 15.5万
• 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 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7637378
• 关键词: Adult Children; Aftercare; Age; American; Anxiety; Berry; Bladder; Brachytherapy; Caring; Characteristics; Clinic; Clinical; Communities; Computer software; Conflict (Psychology); Consult; Consultations; Cryosurgery; Decision Making; Decision Support Systems; Diagnosis; Disease; Evidence based intervention; Excision; External Beam Radiation Therapy; Family; Functional disorder; Hearing; Histology; Home environment; Incidence; Incontinence; Influentials; Internet; Intervention; Intestines; Learning; Life; Location; Mails; Malignant Neoplasms; Malignant neoplasm of prostate; Marathon; Measures; Medical; Misinformation; Modality; Morbidity - disease rate; North America; Online Systems; Operative Surgical Procedures; Outcome; Outcome Measure; Participant; Patient Education; Patients; Perception; Physicians; Platelet Factor 4; Preparation; Process; Prostate; Provider; Public Health Informatics; Quality of life; Radiation Oncologist; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Readiness; Recommendation; Research; Research Personnel; Resources; Risk; Sampling; Services; Site; Specialist; Technology; Testing; Urologic Cancer; Urologist; Visit; Work; alternative treatment; base; cancer therapy; computerized; experience; group intervention; hormone therapy; innovation; insight; man; men; multi-site trial; older men; preference; programs; prostate surgery; satisfaction; secondary outcome; tumor

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(申请人提供)：在前列腺癌发病率高的情况下，没有其他疾病有如此多的选择，而确定性如此之少。局限性前列腺癌(LPC)可以通过几种方法中的一种或多种进行治疗，包括单独观察、手术、冷冻外科、激素治疗、近距离放射治疗或外照射。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、膀胱功能障碍和肠道功能障碍不能轻易在不同的方式之间进行比较。越来越多的证据表明，患有LPC的男性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。已经开发了一个量身定做的决策支持系统，并进行了试点测试，以增强男性个人因素的澄清，在与医生专家的专家咨询中搜索信息和经验。这项随机研究的目的是比较接受个人患者概况-前列腺量表(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变、生活质量和资源利用的比较。这是一个伦理和种族多样化的样本，包括498名患有局限性前列腺癌的男性，他们正在准备一次计划中的咨询访问，与泌尿科医生和/或放射肿瘤学家讨论治疗方案。多个地点的试验将在北美不同的地理位置进行。干预将在两个临床医生办公室或在参与者的宽带互联网接入的家中进行。