Grant Number:	5R01CA068099-08 Interpret this number
Primary Investigator:	Marcus, Alfred
Organization:	University Of Colorado Denver
Project Title:	Promoting Colon Cancer Screening in High-Risk Families
Fiscal Year:	2006

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.





None