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：
7726858
负责人：
PETER Christian RAICH
金额：
$ 17.8万
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/7726858
关键词：
Affect American Cancer Society Biostatistics Core Breast Cancer Treatment CD-ROM Callback Cancer Information Service Cancer Patient Cause of Death Collaborations Compatible Complex Computer software Computers Conflict (Psychology)Control Groups Data Decision Making Diagnosis Disease Distress Dose Early Diagnosis Education Educational Intervention Effect Modifiers (Epidemiology)Eligibility Determination End Point Enrollment Environment Evaluation Event Feasibility Studies Future Goals Group Meetings Health Individual Information Specialists Internet Intervention Interview Knowledge Malignant Neoplasms Measurement Measures Mediator of activation protein Medical Modality Monitor Multimedia Newly Diagnosed Outcome Outcome Measure Participant Patients Personal Computers Physical Function Physician Data Query Physicians Printing Process Protocols documentation Publications Quality Control Quality of life Randomized Range Rate Recommendation Records Recruitment Activity Recurrence Regrets Reporting Research Sampling Science Score Services Stage at Diagnosis Staging Standards of Weights and Measures System Telephone Telephone Interviews Testing Thinking Treatment Efficacy Upper arm Visual Aid Voice Woman breast cancer diagnosis cancer care cancer therapy cohort cost day design desire disorder risk efficacy trial expectation follow-up improved innovation interactive multimedia malignant breast neoplasm outreach programs psychosocial response satisfaction size 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) a callback intervention interview that will be conducted by CIS Information Specialists at 7 days 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. 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 (+) the CIS callback intervention interview. Eligible breast cancer patients who do not report access to a computer at baseline, will be given the opportunity to join a smaller randomized feasibility study, where: Group 1A = Group 1 above, and Group 2A = Group 1A (+) the CIS callback intervention interview. The main 3-arm study will have an enrolled sample at baseline of 360 per arm, for a combined sample of 1080, while the feasibility study will enroll 75 women per arm, for a total of 150. The overall research hypothesis for the main efficacy trial is that the primary study endpoints (including cancerspecific 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). Additional analyses will also be conducted to test both mediator 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. In contrast, the 2-arm feasibility study will be conducted pursuant to a future efficacy trial to be conducted by the CISRC, where feasibility will be assessed in terms of eligibility, participation and cohort retention rates, as well as estimating effect sizes for the primary study endpoints listed above.

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 进行回拨干预访谈信息专家进行 7 天随访。这两项准备性干预措施都将提供信息，对治疗决策以及其他紧急关切和问题的教育和支持。在新诊断的乳腺癌患者中，他们报告在基线时（在他们的治疗期间）使用过计算机通常拨打 CIS 的服务电话），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 (+) 准备多媒体程序;第 3 组 = 第 2 组 (+) CIS 回调干预访谈。符合资格的乳腺癌患者不报告基线时对计算机的访问，将有机会加入较小的随机小组可行性研究，其中：组 1A = 上述组 1，组 2A = 组 1A (+) CIS 回调干预访谈。主要的 3 组研究将在基线时招募每组 360 名样本，合并样本为 1080 人，而可行性研究将每组招募 75 名女性，总共 150 人。主要疗效试验的总体研究假设是主要研究终点（包括癌症特异性苦恼、决策冲突、对决策和知识的满意度）将表现出积极的态度结果与剂量反应梯度一致（即第 3 组 > 第 2 组 > 第 1 组）。额外的还将进行分析以测试中介变量和调节变量。视调查结果而定，一或者这两种干预措施都将在独联体以及其他类似的国家内传播全国范围内的服务项目。相比之下，两臂可行性研究将根据未来的由CISRC进行有效性试验，将根据资格评估可行性，参与率和队列保留率，以及估计主要研究终点的效应大小上面列出的。