Promoting Colon Cancer Screening in High-Risk Families

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。结肠镜检查目前推荐给有两个或更多患有结直肠癌的一级亲属(FDR)的高危家庭成员，或那些年轻时(50岁)有一个FDR伴结直肠癌的家庭成员。调查数据表明，在这些高危人群中，坚持定期结肠镜检查的比率远远低于推荐的水平。这项研究的长期目标是开发一种可输出的干预措施，利用来自癌症遗传学网络(CGN)和结直肠癌研究合作家庭登记(CFRCCS)的合格家庭成员，在这些高危人群中促进定期结肠镜筛查。该提案的具体目标是1)开发一种原型干预措施，在CGN和CFRCCS附属机构的合格高危人群中促进结肠镜检查，以便在随机对照试验中进行测试。这项干预将包括简短的电话教育和障碍咨询，以及后续定制的邮寄和提示卡，以加强干预的电话部分；2)在随机的两组设计(最小干预和更密集的干预)内测试这项干预的有效性；3)潜在的调节因素和中介变量，如果观察到显著的干预效果，将进一步说明和阐明此类影响；4)准备最终报告和论文以供发表。这项建议是对我们癌症预防研究单位(CPRU)对散发性结直肠癌患者FDR非常成功的干预措施的竞争性更新。按照当前CPRU的模式，提出了随机两组设计(基线时每组240人)。CFRCCS和CGN数据协调中心将生成潜在合格受试者的初步名单。最初的联系将由现场研究协调员进行，他们将向研究工作人员提交一份合格和感兴趣的参与者名单，研究工作人员将联系受试者以获得知情同意。所有参与者将完成一份基线邮寄问卷，之后受试者将按家庭单位随机分为最低干预条件和更高强度干预条件。最小干预组将收到一封后续信件，鼓励他们与医生讨论结直肠癌筛查的问题。被随机接受更密集干预的受试者将在应该安排手术的时间之前接受基于电话的教育和咨询干预，一封量身定做的后续信函和一份提醒说明。所有参与者将在6个月、12个月和24个月时完成后续邮寄问卷。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结直肠癌筛查的研究，也是第一项将结肠镜检查作为筛查选择的研究。

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.