Trial Information

Impact of Remote Familial Colorectal Cancer Assessment and Counseling

The rate of adherence to regular colonoscopy screening (CS) among members of families at
increased risk for colorectal cancer (CRC) is far below recommended levels. Persons who live
in rural areas of the United States exhibit lower CRC screening rates than their urban
counterparts. Although the detection of familial predisposition to cancer begins with an
accurate family medical history, data indicate that many patients do not receive adequate
familial cancer risk assessment from their primary care providers. This suggests that
familial risk is largely unrecognized which may lead to inadequate risk stratification, lack
of risk notification, appropriate risk counseling, suboptimal cancer screening and
preventable deaths. Because of geographic and system-level barriers, special efforts are
needed to improve access to personalized risk communication and adherence to CRC screening
to rural and other geographically underserved populations at increased risk for CRC. In the
proposed study, we will evaluate a novel telephone-based, theory-guided personalized risk
communication intervention that combines a familial CRC risk assessment and behavioral
counseling with tailored messages. The key hypothesis guiding this study is that a
multifaceted personalized risk communication intervention will improve CS at a
significantly higher rate than a mailed targeted print intervention.

Our integrative study model specifies important theoretical mechanisms that can contribute
to increased use of CS among persons at increased risk. We will enroll 438 adult men and
women between the ages of 30-74 who are considered at increased risk of familial CRC into
this 2-group randomized trial. The primary aim of this study is to compare colonoscopy use
among participants in the two groups. Secondary aims are to compare the two groups with
regard to cognitive and emotional outcomes and explore the underlying mechanisms through
which the interventions have an impact on colonoscopy behavior. Sociodemographic, clinical,
behavioral and psychosocial measures will be collected from participants at baseline, and 1
month, 9 months, and 15 months following the intervention. Self-reported colonoscopy is
verified with medical records.

The study's findings will have both theoretical, as well as practical significance. Our
findings will help to influence the selection and dissemination of effective outreach
approaches to improve CRC screening in populations at increased risk for the disease. These
results have broad applicability to understanding responses to personalized risk
communication interventions for other diseases as well. Findings will also broaden our
understanding of the underlying theoretical mechanisms of how remote cancer risk
communications lead to improvements in cancer screening among geographically underserved
populations if such intervention effects are observed.

In addition to studying the intervention effects in rural areas, we will enroll participants
in urban areas. These enhancements to our population-based randomized behavioral trial will
provide us with an unprecedented opportunity to assess reach and determine if there are
differential intervention effects (i.e., efficacy) with regard to place of residence
(rurality vs. urbanicity.)