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Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)

ABSTRACT: This study will adapt and test a touch-screen computer program to evaluate cancer risk and provide patient-tailored recommendations for appropriate risk-based testing. This individually tailored intervention delivered right at the point of primary care and just prior to the office visit, can be a helpful and non-obstructive adjunct to clinical care. The primary aim of this project is to test whether a tailored intervention promoting risk-appropriate cancer testing results increases participation compared with a simple non-tailored reminder or no reminder. The trial is designed to determine the extent to which the Cancer Risk Intake System (CRIS) facilitates (1) participation in risk-appropriate colorectal cancer testing, as documented by electronic medical record audit; (2) patient receipt of risk-appropriate colorectal cancer testing recommendations from their physicians, as documented by electronic medical record audit; and (3) changes in patients’ intent to participate in risk-appropriate colorectal cancer testing, as documented by patient report. The Family and Community Medicine and General Internal Medicine clinic databases will be used to identify potentially eligible patients with upcoming scheduled appointments. Because physicians will be the unit of random assignment, patients will be coded before study invitation as potential participants in the intervention or the comparison group. A random sample of eligible intervention and comparison group patients will be selected for contact. Identified patients will be mailed letters from the practices and signed by their physicians requesting their participation. The letters will describe a "study of beliefs and practices about cancer prevention and early detection" and will provide a toll-free number to refuse contact. One week after the mailing, patients who have not called to refuse contact will be called by study staff to explain the study, verify eligibility and, if the patient agrees, to arrange an in-person meeting at the clinic 30 minutes prior to their appointment. These calls will be made by trained research assistants who will follow standard calling protocols. After consent, participants will complete the computerized data collection (CRIS) immediately prior to a scheduled primary-care appointment. Intervention group patients and their physicians will receive a printout recommending risk-appropriate colorectal testing and ways to overcome perceived barriers to testing. A member of the research team will hand the patient his or her printout and will deliver the other printout to the physician. Comparison group patients and physicians will receive non-tailored printouts that are simple reminders about testing. The investigators will also establish a true no-contact control by conducting a retrospective chart review for randomly selected patients who did not receive an invitation to participate in the study. This no-contact control will establish a baseline screening rate. The investigators will then conduct analysis with the comparison and intervention group to see if individuals who participate in CRIS have a higher screening rate for colorectal cancer compared to the non-contact group. These additional data will help us better assess study Aims 1 and 2.

DISEASE(S): Colorectal Neoplasms,Colonic Neoplasms,Neoplasms

PROVIDER: 2184201 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background: We tested the hypothesis that short-term supplementation with a physiological dose of folate can alter global gene expression in the colon of subjects with colorectal adenoma using a randomised double blind placebo controlled trial design. Materials and Methods: Fourteen subjects with histologically confirmed colorectal adenoma, randomised to receive folic acid (400M-BM-5g/d, n=6) or placebo (n=8) for 10 weeks, had blood samples and colonic tissue biopsies collected before and after the intervention. Blood samples were used to determine serum and red cell folate, plasma homocysteine, and genetic polymorphisms in methylenetetrahydrofolate reductase (MTHFR C677T) and methionine synthase (MS A2756G). RNA extracted from normal-appearing colonic tissue samples was used to determine global gene expression in the colon using AffymetrixM-oM-^CM-^R Microarray GeneChips. Microarray results were confirmed by quantitative real time RT-PCR. Two methods were used to analyse the microarray data: (1) differences between pre- and post-intervention gene expression values in the folic acid and placebo groups separately using paired-sample t tests; (2) differences between the folic acid and placebo groups in the ratio of post-intervention to pre-intervention gene expression values using independent sample t-tests. Results: (1) Following intervention, sixty seven genes were up-regulated and 13 genes were down-regulated in the folic acid group, while 21 genes were up-regulated and none were down-regulated in the placebo group (P<0.05, adjusted for multiple testing). (2) Thirty six genes were up-regulated and 18 genes were down-regulated in the folic acid group when compared with placebo, but none of these were statistically significant after adjustment for multiple testing. These genes are involved in multiple pathways, including cell cycle, signal transduction, cell differentiation, transport, cell division, cell motility, protein transport and immune response. There were no genes involved in 1-carbon metabolism that were altered in expression, although several genes involved in neoplasia were up-regulated. Conclusions: These results indicate that while folic acid can modify gene expression, it is difficult to separate its effects from the natural variability in gene expression in the colon. Fourteen patients with colorectal adenoma were treated with either folate supplementation (6 subjects) or a placebo (8 subjects) for 10 weeks in a randomised double-blind trial. Colonic biopsies of normal tissue were taken before and after the intervention, and analysed for gene expression.

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Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)

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