权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Promoting Colon Cancer Screening in High-Risk Families

促进高危家庭结肠癌筛查

基本信息

批准号：
7661743
负责人：
DENNIS J AHNEN
金额：
$ 3.18万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
1995
资助国家：
美国
起止时间：
1995-09-30 至 2009-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7661743
关键词：
Adherence Age Age-Years American American Cancer Society Cancer Family Cancer Genetics Network Caring Clinical Colon Carcinoma Colonoscopy Colorectal Cancer Communication Condition Counseling Data Data Coordinating Center Education Effectiveness of Interventions End Point Enrollment Family Family history of Family member Family-Based Registry First Degree Relative Funding Goals Grant Hereditary Nonpolyposis Colorectal Neoplasms Informed Consent Inherited Institution International Intervention Letters Mails Malignant Neoplasms Mediating Medical Surveillance National Comprehensive Cancer Network Oncogenes Paper Participant Patients Pattern Physicians Population Predisposition Prevention Research Procedures Publications Questionnaires Randomized Randomized Controlled Trials Range Rate Recommendation Registries Reporting Research Research Personnel Risk Risk Factors Schedule Screening procedure Secondary Prevention Site Specific qualifier value Standards of Weights and Measures Surveys Telephone Testing Time Treatment Efficacy base cancer genetics cancer prevention college colorectal cancer prevention colorectal cancer screening design follow-up interest member neoplasm registry programs prototype

项目摘要

DESCRIPTION (provided by applicant): A strong family history is an important risk factor for colorectal cancer. Colonoscopic screening is currently recommended for members of high-risk families with two or more first-degree relatives (FDRs) with colorectal cancer, or those who have one FDR with CRC at a young age (< 50 years of age). Survey data indicate that the rate of adherence to regular colonoscopic screening among these high-risk populations is far below recommended levels. The long-range goal of this study is to develop an exportable intervention to promote regular colonoscopic screening among these high-risk populations, using eligible family members drawn both from the Cancer Genetics Network (CGN) and the Collaborative Family Registry for Colorectal Cancer Studies (CFRCCS). The specific aims of the proposal are 1) Develop a prototype intervention to promote colonoscopic surveillance among the eligible high-risk populations of participating institutions affiliated with the CGN and the CFRCCS, for testing in a randomized controlled trial. This intervention will include brief telephone education and barriers counseling with a follow-up tailored mail-out and reminder card to reinforce the telephone component of the intervention; 2) Test this intervention for efficacy within a randomized two-group design (minimal intervention vs. a more intensive intervention); 3) ExpIorepotential moderator and mediating variables that will further specify and elucidate significant intervention effects, if such effects are observed; 4) Prepare a final report and papers for publication. This proposal is a competitive renewal of a highly successful intervention in FDRs of patients with sporadic CRC that was part of our Cancer Prevention Research Unit (CPRU). A randomized two-group design is proposed (n=240 per group at baseline), patterned after the current CPRU. The CFRCCS and the CGN data coordinating centers will generate the initial list of potentially eligible subjects. The initial contact will be made by the on-site study coordinators who will submit a list of eligible and interested enrollees to the study staff who will contact the subject to obtain informed consent. All participants will complete a baseline mail questionnaire after which subjects will be randomized by family unit to the minimal vs. the more intensive intervention condition. The minimal intervention group will receive a follow-up letter to encourage them to talk with their physician about CRC screening. Subjects randomized to the more intensive intervention will receive a telephone-based education and counseling intervention, a tailored follow-up letter, and a reminder note just prior to the time the procedure should be scheduled. All participants will complete follow-up mail questionnaires at 6, 12 and 24 months. The primary endpoint of the study is the rate of adherence to recommended colonoscopy screening. When completed, this would be the first study to target these high-risk populations for CRC screening and the first study to target colonoscopy as the screening test of choice.

描述（由申请人提供）：强烈的家族史是结直肠癌的重要危险因素。结肠镜筛查目前推荐用于有两个或更多个一级亲属（FDR）患有结直肠癌的高危家庭成员，或那些在年轻时（< 50岁）有一个FDR患有CRC的人。调查数据表明，在这些高危人群中，定期结肠镜筛查的依从率远低于推荐水平。这项研究的长期目标是开发一种可输出的干预措施，以促进这些高危人群中的定期结肠镜筛查，使用来自癌症遗传学网络（CGN）和结直肠癌研究协作家庭登记处（CFRCCS）的合格家庭成员。该提案的具体目标是：1）开发一种原型干预措施，以促进CGN和CFRCCS附属参与机构的合格高危人群的结肠镜监测，并在随机对照试验中进行测试。该干预将包括简短的电话教育和障碍咨询，并提供后续定制的邮件和提醒卡，以加强干预的电话部分; 2）在随机两组设计中测试该干预的有效性（最小干预与更密集的干预）; 3）如果观察到显著的干预效果，将进一步说明和阐明这种效果的潜在调节变量和中介变量; 4）准备最终报告和论文以供出版。该提案是对我们癌症预防研究单位（CPRU）的一部分，对散发性CRC患者的FDR进行非常成功的干预的竞争性更新。根据当前CPRU的模式，提出了随机化两组设计（基线时每组n=240）。 CFRCCS和CGN数据协调中心将生成潜在合格受试者的初始列表。初步联系将由现场研究协调员进行，协调员将向研究工作人员提交合格和感兴趣的入组者名单，研究工作人员将联系受试者以获得知情同意。所有受试者将完成基线邮寄问卷，之后受试者将按家庭单位随机分配至最低干预条件与更强化干预条件。最低干预组将收到一封随访信，鼓励他们与医生讨论CRC筛查。随机分配到更强化干预组的受试者将在计划手术前接受电话教育和咨询干预、定制随访信和提醒说明。所有参与者将在6个月、12个月和24个月时完成随访邮件问卷。该研究的主要终点是对推荐的结肠镜筛查的依从率。完成后，这将是第一项针对这些高危人群进行CRC筛查的研究，也是第一项针对结肠镜检查作为筛查试验的研究。