Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anita Kinney, University of Utah
ClinicalTrials.gov Identifier:
NCT01274143
First received: December 10, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Colorectal Cancer
Behavioral: TeleCARE
Behavioral: Pamphlet intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Remote Familial Colorectal Cancer Assessment and Counseling

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Colonoscopy [ Time Frame: 9 month follow-up ] [ Designated as safety issue: No ]
    The primary outcome is colonoscopy. Medical record verification of self-reported colonoscopy is performed.


Secondary Outcome Measures:
  • Fecal occult blood test (FOBT)/Fecal Immunochemical Test (FIT) [ Time Frame: Baseline, 1 month, 9 month, and 15 month follow-up ] [ Designated as safety issue: No ]
    Fecal occult blood test(FOBT) following the intervention. Medical confirmation of self-reported FOBT/FIT is performed.

  • Perceived Control [ Time Frame: Baseline, 1 month and 9 month follow-up ] [ Designated as safety issue: No ]
    The Perceived Personal Control Scale is an integrative outcome that encompasses the broad spectrum of health risk communication and informed decision-making. This validated scale is a 9-item measure representing three dimensions of control participants believe they have regarding family history of colorectal cancer (CRC): cognitive-interpretive, decisional, and behavioral. A 5-point Likert-style response format is used ranging from very little control to very high control. A total scale score is calculated by summing the items.

  • Perceived Risk [ Time Frame: Baseline, 1 month and 9 month follow-up ] [ Designated as safety issue: No ]
    A 4-item scale with established construct and predictive validity with regard to cancer screening will assess participants' subjective perceived risk for developing colorectal cancer. Responses are measured on a five-point Likert scale ranging from very small to very large.

  • Psychological distress [ Time Frame: Baseline, 1 month and 9 month follow-up ] [ Designated as safety issue: No ]
    Generalized psychological distress will be operationalized as state anxiety and we will use the State Subscale of the State Trait Anxiety Inventory. We will also measure cancer-specific distress with the Impact of Event Scale. The stressor in this study is having a family history of colorectal cancer.

  • Knowledge [ Time Frame: Baseline, 1 month and 9 month follow-up ] [ Designated as safety issue: No ]
    The Colorectal Cancer Knowledge Survey is a validated 12-item scale that assesses colorectal cancer screening knowledge, colorectal cancer risk factors (including family history) and CRC symptoms. The questionnaire consists of true/false with a possible range of scores of 0-12. FOBT items will be substituted with colonoscopy.

  • Decisional Conflict [ Time Frame: Baseline, 1 month and 9 month follow-up ] [ Designated as safety issue: No ]
    Participants are asked to evaluate whether or not they feel confident in their decision to receive or not receive CRC screening. Assessment following the intervention will determine whether the decisional conflict has been resolved and whether or not that resolution results in colonoscopy uptake.


Enrollment: 496
Study Start Date: May 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telephone-delivered risk intervention
Participants in this arm receive a personalized telephone-risk assessment intervention provided by a trained cancer risk counselor.
Behavioral: TeleCARE
Personalized telephone-delivered cancer risk assessment.
Active Comparator: Mailed pamphlet intervention group
Participants in this group receive a mailed pamphlet containing information about familial colorectal cancer risk and screening.
Behavioral: Pamphlet intervention
Mailed pamphlet about familial colorectal cancer risk and screening.

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.)

  Eligibility

Ages Eligible for Study:   30 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274143

Locations
United States, California
California Cancer Registry
Sacramento, California, United States, 95825
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Colorado Central Cancer Registry
Denver, Colorado, United States, 80246
United States, Idaho
Cancer Data Registry of Idaho
Boise, Idaho, United States, 83701
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Utah Cancer Registry
Salt Lake City, Utah, United States, 84112
Intermountain Health Care
Salt Lake City, Utah, United States, 84111
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Anita Y Kinney, Ph.D., R.N. Huntsman Cancer Institute and University of Utah
  More Information

No publications provided by University of Utah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anita Kinney, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01274143     History of Changes
Other Study ID Numbers: IRB_00017894
Study First Received: December 10, 2010
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Colorectal
Cancer
Colon
Rectal
Behavioral Intervention
Screening
Motivational Interviewing
Extended Parallel Process Model
Implementation Intentions
Family CARE

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 22, 2014