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Impact of Remote Familial Colorectal Cancer Assessment and Counseling

30 Years
74 Years
Not Enrolling
Colorectal Cancer

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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.)

Inclusion Criteria:

- Have at least one first-degree relative diagnosed with colorectal cancer (CRC)
between the ages of 40-59, or one first-degree relative diagnosed with colorectal
cancer at age 40 or older and an additional first-degree or second-degree relative
diagnosed with colorectal cancer at age 40 or older.

- If relative was diagnosed over age 50, participant must be 40-74 years old.

- If relative was diagnosed at age 40-49, participant cannot be more than ten years
younger than relative at first diagnosis (e.g., dx at 48, participant must be 38-74
years old).

- Colorectal cancer cases of relatives recruited through the cancer registries of
California, Colorado, Idaho, New Mexico, or Utah; Rocky Mountain Cancer Genetics
Coalition sites of National Cancer Genetics Network in Colorado, New Mexico, or Utah;
or Intermountain Health Care

Exclusion Criteria:

- Previous cancer diagnosis of any kind (except for non-melanoma skin cancers).

- Has had a colonoscopy within the past five years.

- Meets clinical criteria for Lynch syndrome or other polyposis syndromes.

- Has had prior involvement in colorectal cancer-related clinical, behavioral or
epidemiologic cancer familial research.

- Mentally incompetent, incarcerated, hearing or visually impaired.

- Unable to read and speak English fluently.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:


Outcome Description:

The primary outcome is colonoscopy. Medical record verification of self-reported colonoscopy is performed.

Outcome Time Frame:

9 month follow-up

Safety Issue:


Principal Investigator

Anita Y Kinney, Ph.D., R.N.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute and University of Utah


United States: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

April 2013

Related Keywords:

  • Colorectal Cancer
  • Colorectal
  • Cancer
  • Colon
  • Rectal
  • Behavioral Intervention
  • Screening
  • Motivational Interviewing
  • Extended Parallel Process Model
  • Implementation Intentions
  • Family CARE
  • Colorectal Neoplasms



University of Colorado Cancer Center Denver, Colorado  80262
Huntsman Cancer Institute Salt Lake City, Utah  84112
University of New Mexico Albuquerque, New Mexico  87131
Intermountain Health Care Salt Lake City, Utah  84103
California Cancer Registry Sacramento, California  95825
Colorado Central Cancer Registry Denver, Colorado  80246
Cancer Data Registry of Idaho Boise, Idaho  83701
Utah Cancer Registry Salt Lake City, Utah  84112