PSYCHOSOCIAL PROCESSES IN CLINICAL TRIAL ACCEPTANCE

描述：八分之一的女性可能会患上乳腺癌， 将面临做出医疗决策， 对疾病的治疗有很大帮助虽然这些妇女中有许多人将 有资格参加临床试验，大多数 他们不会被录取。研究人员发现， 医疗、财务、医生和患者因素， 禁止接受临床试验。本研究的目的是 运用说服力领域的理论和方法 调查三位医生的影响 （源）变量（医生对试验的热情，医生 隶属关系和医患关系的类型）和各种 患者（接受者）因素（既往癌症经验、状态， 特质和癌症特有的焦虑，抑郁，乐观， 治疗参与的首选水平） 临床试验，信息处理，信息回忆，医师 评价和情感反应。使用Escort 本研究以李克群模型为概念框架， 两阶段设计。在第一阶段，一系列的视频记录 通信将被开发和测试其诱导能力， 医生变量的期望操作。 八聚焦 小组将进行测试的视频（四个与前乳房 癌症患者和四名从未患过癌症的妇女）， 如有需要，录像将予修订。 在第二阶段， 将采用析因设计，每个牢房24名妇女，分为两组 女性（乳腺癌和非乳腺癌）。在这个阶段， 妇女将完成（广泛的信息前和信息后问卷， 评估患者因素和结果变量。）具体目标 （1）制作录像信息，充分描述 实验操作（第一阶段）;（2）研究主要的 以及医生和患者因素对 接受、理解和解释临床试验 第二阶段：（3）探讨本研究方法的可行性 进一步研究医患沟通和知情 患者参与临床试验决策。

DESCRIPTION: One in eight women will likely develop breast cancer in her lifetime and will be faced with making medical decisions related to the treatment of the disease. While many of these women will be eligible for participation in a clinical trial, the majority of them will not be enrolled. Researchers have identified institutional, medical, financial, physician and patient factors that facilitate or inhibit acceptance of clinical trials. The goal of this study is to use theories and methods from the field of persuasive communications to investigate the effects of three physician (source) variables (physician enthusiasm for the trial, physician affiliation, and type of physician-patient relationship) and a variety of patient (receiver) factors (previous experience with cancer, state, trait and cancer-specific anxiety, depression, optimism, and preferred level of treatment involvement) on acceptance of the clinical trial, information processing, information recall, physician evaluation, and affective responses. Using the Elaboration Likelihood Model as the conceptual framework, the study will employ a two- phase design. In phase one, a series of video recorded communications will be developed and tested for their ability to induce the desired manipulations of the physician variables. Eight focus groups will be conducted to test the videos (four with former breast cancer patients and four with women who have never had cancer) and the videos will be revised if necessary. During phase two, a 2x2x2 factorial design will be employed with 24 women per cell for two groups of women (breast cancer and non-breast cancer). During this phase, women will complete (extensive pre- and post-message questionnaires to assess patient factors and the outcome variables.) The specific aims are to: (1) develop video recorded messages that adequately depict the experimental manipulations (phase one); (2) investigate the main and interactive effects of physician and patient factors on the acceptance, comprehension, and interpretation of clinical trials (phase two); (3) investigate the feasibility of this research approach for further studies on physician-patient communication and informed patient involvement in clinical trial decision-making.