A randomized trial of genetic and environmental risk assessment (GERA) for colorectal cancer risk in primary care: Trial design and baseline findings

Abstract

Purpose-This paper describes an ongoing randomized controlled trial designed to assess the impact of genetic and environmental risk assessment (GERA) on colorectal cancer (CRC) screening.Methods-The trial includes asymptomatic patients who are 50-79 years and are not up-to-date with CRC screening guidelines. Patients who responded to a baseline telephone survey are randomized to a GERA or Control group. GERA Group participants meet with a nurse, decide whether to have a GERA blood test (a combination of genetic polymorphism and folate), and, if tested, receive GERA feedback. Follow-up telephone surveys are conducted at one and six months. A chart audit is performed at six months.Results-Of 2,223 eligible patients, 562 (25%) have enrolled. Patients who enrolled in the study were significantly younger than those who did not (p<0.001). Participants tended to be 50-59 years (64%), female (58%), white (52%), married (51%), and have more than a high school education (67%). At baseline, most participants had some knowledge of CRC screening and GERA, viewed CRC screening favorably, and reported that they had decided to do screening. Almost half had worries and concerns about CRC.

“Is it Really Worth it to Get Tested?”: Primary Care Patients’ Impressions of Predictive SNP Testing for Colon Cancer

“…Primary care practitioners likely will not have the time or expertise to appropriately convey predictive risk information (McGuire et al, 2009; Rafi et al, 2009); consequently, development of alternate models to deliver genetic and genomic information is important. Examples of alternative models include specialized training for nurse practitioners (Myers et al, 2011) or inclusion of genetics specialists within primary care settings (Battista, Blancquaert, Laberge, van Schendel, & Leduc, 2012). Although delivering individual SNP-level genomic results through genetic counselors is not tenable or likely even necessary at the population/public health level (O'Daniel, 2010; Pagon, 2002), arguments for including genetic counselors in the process include their unique ability to convey complex risk information, accurate assessment of family history, and provision of expert guidance in certain situations like whole genome sequencing (O'Daniel, 2010).…”

Genetic and Environmental Risk Assessment and Colorectal Cancer Screening in an Average-Risk Population

“…Participants also responded to previously described questionnaires regarding CRC screening knowledge and the possible role of genes and diet in cancer development. 17 Finally, they completed the Impact of Event Scale (IES), a well validated assessment tool for psychological distress. 18 …”

Predictors of patient uptake of colorectal cancer gene environment risk assessment

“…A detailed description of the GERA methods has been published [31]. In brief, eligible participants for the GERA study include average risk adults non-compliant with recommended CRC screening.…”

“…Selection of measures for the baseline survey for the larger randomized GERA clinical trial is guided by two behavioral health models, the Preventive Health Model and the Precaution Adoption Process Model [31,36,37]. The former predicts that preventive health behaviors may be influenced by demographic factors, cognitive perceptions of the health threat, and perceived risk of the health threat [36,37].…”

“…Our research group recently reported on the feasibility of offering a gene-environment risk assessment (GERA) study in which testing results for two markers of CRC risk, serum folate level and two SNPs in the MTHFR gene (methylentetrahydrofolate reductase), were made available to adults at average risk for CRC [30,31]. An ongoing randomized study is currently examining the impact of GERA testing on CRC screening compliance.…”