PREPARATORY INTERVENTIONS FOR BREAST CANCER PATIENTS

乳腺癌患者的预备干预措施

基本信息

批准号：
8120896
负责人：
PETER Christian RAICH
金额：
$ 13.26万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/8120896
关键词：
Affect American Cancer Society Biostatistics Core Breast Cancer Treatment CD-ROM Callback Cancer Information Service Cancer Patient Cause of Death Collaborations Complex Computer software Computers Conflict (Psychology)Control Groups Data Decision Making Diagnosis Disease Distress Dose Early Diagnosis Education Educational Intervention Effect Modifiers (Epidemiology)Enrollment Environment Evaluation Event Future Goals Group Meetings Health Individual Information Specialists Internet Intervention Interview Knowledge Malignant Neoplasms Measurement Measures Mediator of activation protein Medical Modality Monitor Moods Multimedia Newly Diagnosed Outcome Outcome Measure Participant Patient Self-Report Patients Personal Computers Physical Function Physicians Printing Process Protocols documentation Publications Quality Control Quality of life Randomized Recommendation Records Recruitment Activity Recurrence Reporting Research Sampling Science Services Stage at Diagnosis Staging System Telephone Telephone Interviews Testing Thinking Treatment Efficacy Visual Aid Voice Woman base breast cancer diagnosis cancer care cancer therapy cost design disorder risk expectation follow-up improved innovation interactive multimedia malignant breast neoplasm outreach programs psychosocial randomized trial response satisfaction therapy development tool virtual

项目摘要

Women with recently diagnosed early stage breast cancer are faced with multiple decisions that will impact their survival and quality of life. The availability of timely, relevant, and accurate health information for patients is crucial in this context. This study (Project 2) will develop and test two preparatory interventions for newly diagnosed early-stage breast cancer patients who call the Cancer Information Service of the NCI: 1) a state-of-the-science and highly interactive multimedia program that will be offered to patients in two platforms (CD-ROM, Internet), and 2) two callback intervention interviews that will be conducted by CIS Information Specialists at 5 days and 2 weeks follow-up. Both of these preparatory interventions will provide information, education and support for treatment decision-making as well as other emergent concerns and issues. Both will be evaluated for efficacy in two complementary randomized trials. Among newly diagnosed breast cancer patients who report access to a computer at baseline (during their usual service call to the CIS), a randomized three-group stepped design will be used, where: Group 1 = standard CIS service (+) standard CIS print material; Group 2 = Group 1 (+) the preparatory multimedia program; Group 3 = Group 2 (+) two CIS callback intervention interviews. Among eligible breast cancer patients who do not report access to a computer at baseline, a randomized two-group design will be used, where: Group 1A = Group 1 above, and Group 2A = Group 1A (+) two CIS callback intervention interviews. Each of the above experimental groups will have an enrolled sample at baseline of 360, for a combined sample of 1800. The overall research hypothesis is that the main study endpoints (including cancer-specific distress, decisional conflict, satisfaction with decision-making and knowledge) will show positive outcomes consistent with a dose-response gradient (i.e., Group 3 > Group 2 > Group 1, Group 2A > 1 A). Additional analyses will also be conducted to test both mediational and moderator variables. Contingent on findings, one or both of these interventions will be offered for dissemination within the CIS, as well as in other similar service programs nationwide.

最近诊断出早期乳腺癌的女性面临着多项决定，这些决定将影响他们的生存和生活质量。及时、相关和准确的健康信息的可用性在这种情况下，患者至关重要。本研究（项目 2）将开发和测试两种预备干预措施对于致电 NCI 癌症信息服务中心的新诊断早期乳腺癌患者： 1) 一个最先进、高度互动的多媒体程序，将分两期向患者提供平台（CD-ROM、互联网），以及 2）由 CIS 进行的两次回调干预访谈信息专家进行 5 天和 2 周的随访。这两项准备性干预措施都将为治疗决策以及其他紧急情况提供信息、教育和支持关切和问题。两者的疗效将在两项互补的随机试验中进行评估。之中新诊断的乳腺癌患者报告在基线时（在他们平常的时间里）使用过计算机致电 CIS），将使用随机三组阶梯式设计，其中：第 1 组 = 标准 CIS服务（+）标准CIS打印材料；第2组=第1组（+）预备多媒体节目；第 3 组 = 第 2 组 (+) 两次 CIS 回调干预访谈。符合资格的乳腺癌患者中如果不报告基线时对计算机的访问情况，将使用随机两组设计，其中： 1A = 上述第 1 组，第 2A 组 = 1A 组 (+) 两次 CIS 回调干预访谈。每个上述实验组的基线登记样本为 360 人，合并样本为 1800 人。总体研究假设是主要研究终点（包括癌症特异性痛苦、决策冲突、对决策和知识的满意度）将显示出一致的积极结果具有剂量反应梯度（即第 3 组 > 第 2 组 > 第 1 组，第 2A 组 > 1 A）。附加分析还将测试中介变量和调节变量。视调查结果而定，一项或多项这两项干预措施将在独联体以及其他类似服务中传播全国范围内的计划。