Promoting Colon Cancer Screening in High-Risk Families

促进高危家庭结肠癌筛查

• 批准号: 6681566
• 负责人: DENNIS J AHNEN
• 金额: $ 63.6万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6681566
• 关键词: cancer prevention; clinical research; colorectal neoplasms; data collection; education evaluation /planning; endoscopy; family genetics; gastrointestinal imaging /visualization; genetic counseling; genetic susceptibility; human subject; neoplasm /cancer diagnosis; neoplasm /cancer education; questionnaires; telemedicine

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。目前，对于有两个或两个以上一级亲属（FDR）患有结直肠癌的高危家庭成员，或有一个一级亲属在年轻时（< 50岁）患有结直肠癌的家庭成员，建议进行结肠镜筛查。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建议水平。本研究的长期目标是开发一种可输出的干预措施，以促进这些高风险人群的定期结肠镜筛查，使用来自癌症遗传学网络（CGN）和结直肠癌研究合作家庭登记处（CFRCCS）的符合条件的家庭成员。该提案的具体目的是：1)开发一种原型干预措施，以促进中广核和CFRCCS所属参与机构中符合条件的高危人群进行结肠镜监测，并在随机对照试验中进行测试。这一干预措施将包括简短的电话教育和障碍咨询，并附带量身定制的后续邮寄和提醒卡，以加强干预措施的电话部分；2)在随机两组设计中测试该干预措施的有效性（最小干预与更强化的干预）；3)探索潜在的调节和中介变量，如果观察到显著的干预效果，这些变量将进一步指定和阐明显著的干预效果；4)准备最终报告和论文发表。该建议是对散发性结直肠癌患者fdr非常成功干预的竞争性更新，该干预是我们癌症预防研究部门（CPRU）的一部分。建议采用随机两组设计（基线时每组n=240），以当前CPRU为模板。CFRCCS和CGN数据协调中心将生成潜在合格受试者的初步名单。初步联系将由现场研究协调员进行，他将向研究人员提交一份符合条件和感兴趣的受试者名单，研究人员将与受试者联系以获得知情同意。所有参与者将完成一份基线邮件调查问卷，之后受试者将按家庭单位随机分配到最小和更密集的干预条件。最小干预组将收到一封后续信，鼓励他们与医生讨论结直肠癌筛查。随机分配到更密集干预的受试者将接受基于电话的教育和咨询干预，量身定制的随访信，以及在程序应该安排的时间之前的提醒通知。所有参与者将在6个月、12个月和24个月完成随访邮件问卷。该研究的主要终点是推荐结肠镜筛查的依从率。一旦完成，这将是第一个针对这些高危人群进行CRC筛查的研究，也是第一个将结肠镜检查作为首选筛查试验的研究。