Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project) is
      designed to determine whether a personalized telephone plus mailed print cancer risk
      assessment and behavior change counseling intervention is more effective than a targeted
      mailed print intervention in promoting risk appropriate screening in individuals with a
      family history of the disease. The project targets people residing in both rural and urban
      areas, allowing an examination of differential intervention effects with regard to place of
      residence.
    

Detailed description: 
      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.)
    

Intervention name(s): TeleCARE; Pamphlet intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Personalized telephone-delivered cancer risk assessment.; Mailed pamphlet about familial colorectal cancer risk and screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Colorectal; Cancer; Colon; Rectal; Behavioral Intervention; Screening; Motivational Interviewing; Extended Parallel Process Model; Implementation Intentions; Family CARE