BUDDY PROGRAM FOR BREAST CANCER CLINICAL TRIALS

乳腺癌临床试验好友计划

• 批准号: 2009686
• 负责人: ALLISON C MORRILL
• 金额: $ 6.83万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至 2000-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2009686
• 关键词: breast neoplasms; clinical trials; decision making; female; human subject; interview; social support network

DESCRIPTION: This pilot project aims to develop, evaluate and refine a buddy program for women who are eligible to participate in breast cancer clinical trials. Each potential recruit will be assigned a buddy--a volunteer who has already participated in a similar breast cancer clinical trial--to provide information and support through the decision-making process. The intent of the buddy program is to increase enrollment of women in breast cancer clinical trials, especially women of minority ethnicity and women with limited education. The pilot project has three phases: (1) develop protocols, and recruit and train 12 buddies (6 months); (2) implement the buddy program for 60 patients (l year); and (3) assess and refine the program (6 months). The buddy will meet with the patient in person at least once, and then be available as needed until the patient has reached a decision (average 2-5 weeks). She will reinforce, in lay terms, the information provided by health professionals and supplement it by describing her own personal experiences, both good and bad. This will help the patient to be better prepared for trial participation, not only cognitively, but also at the emotional level. Better preparation should in turn increase enrollment. After reaching a decision about the trial, participants will be interviewed about their experience in the buddy program, their utilization of the buddy, their assessment of the program's helpfulness, its impact on the clinical trial decision and decision-making process, and their suggestions for improving the program. Buddies will complete a written report on the same topics and participate in a final meeting to evaluate the program and make recommendations as a group. The information from this pilot project will inform refinements to the design of the buddy program. The program will then be ready for testing in a larger, randomized study of its effectiveness as a recruitment tool.

描述：这一试点项目旨在开发、评估和完善 为有资格参加丰胸手术的女性提供伙伴计划 癌症临床试验。每个潜在的新兵都将被分配一个 巴迪--一位已经做过类似乳房手术的志愿者 癌症临床试验--通过 决策过程。伙伴计划的目的是 增加女性参加乳腺癌临床试验的人数， 特别是少数族裔妇女和受教育程度有限的妇女。 试点项目分三个阶段：(1)制定方案，招募 并培训12名伙伴(6个月)；(2)实施伙伴计划 60例患者(L年)；(3)评估和完善方案(6 月)。这位伙伴至少会亲自与病人见面。 一次，然后根据需要随时可用，直到患者到达 一个决定(平均2-5周)。她将以外行的方式加强， 由卫生专业人员提供的信息，并通过 描述她自己的个人经历，包括好的和不好的。这将是 帮助患者为参与试验做好更好的准备，而不是 不仅在认知上，而且在情感层面上也是如此。更好的准备 应该反过来增加招生人数。在作出决定后 关于试验，参与者将被采访关于他们的 伙伴计划的经验，他们对伙伴的利用，他们的 评估该计划的帮助及其对临床的影响 审判决定和决策过程，以及他们对 完善该计划。巴迪将完成一份关于 相同的主题，并参加最后一次会议以评估计划 并作为一个小组提出建议。这位飞行员提供的信息 项目将通知改进伙伴计划的设计。 然后，该计划将准备好在更大的、随机的 研究其作为招聘工具的有效性。