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

NCT ID: NCT01274143

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 496 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2013-04-30

Brief 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.)

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Telephone-delivered risk intervention

Participants in this arm receive a personalized telephone-risk assessment intervention provided by a trained cancer risk counselor.

Group Type: ACTIVE_COMPARATOR

TeleCARE

Intervention Type: BEHAVIORAL

Personalized telephone-delivered cancer risk assessment.

Mailed pamphlet intervention group

Participants in this group receive a mailed pamphlet containing information about familial colorectal cancer risk and screening.

Group Type: ACTIVE_COMPARATOR

Pamphlet intervention

Intervention Type: BEHAVIORAL

Mailed pamphlet about familial colorectal cancer risk and screening.

Interventions

TeleCARE

Personalized telephone-delivered cancer risk assessment.

Intervention Type: BEHAVIORAL

Pamphlet intervention

Mailed pamphlet about familial colorectal cancer risk and screening.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Anita Kinney

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute and University of Utah

Locations

California Cancer Registry

Sacramento, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Colorado Central Cancer Registry

Denver, Colorado, United States

Cancer Data Registry of Idaho

Boise, Idaho, United States

University of New Mexico

Albuquerque, New Mexico, United States

Intermountain Health Care

Salt Lake City, Utah, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Utah Cancer Registry

Salt Lake City, Utah, United States

Countries

United States

References

Brumbach BH, Birmingham WC, Boonyasiriwat W, Walters S, Kinney AY. Intervention Mediators in a Randomized Controlled Trial to Increase Colonoscopy Uptake Among Individuals at Increased Risk of Familial Colorectal Cancer. Ann Behav Med. 2017 Oct;51(5):694-706. doi: 10.1007/s12160-017-9893-1.

Reference Type: DERIVED

PMID: 28236077 (View on PubMed)

Anderson AE, Flores KG, Boonyasiriwat W, Gammon A, Kohlmann W, Birmingham WC, Schwartz MD, Samadder J, Boucher K, Kinney AY. Interest and informational preferences regarding genomic testing for modest increases in colorectal cancer risk. Public Health Genomics. 2014;17(1):48-60. doi: 10.1159/000356567. Epub 2014 Jan 14.

Reference Type: DERIVED

PMID: 24435063 (View on PubMed)

Boonyasiriwat W, Hung M, Hon SD, Tang P, Pappas LM, Burt RW, Schwartz MD, Stroup AM, Kinney AY. Intention to undergo colonoscopy screening among relatives of colorectal cancer cases: a theory-based model. Ann Behav Med. 2014 Jun;47(3):280-91. doi: 10.1007/s12160-013-9562-y.

Reference Type: DERIVED

PMID: 24307472 (View on PubMed)

Simmons RG, Lee YC, Stroup AM, Edwards SL, Rogers A, Johnson C, Wiggins CL, Hill DA, Cress RD, Lowery J, Walters ST, Jasperson K, Higginbotham JC, Williams MS, Burt RW, Schwartz MD, Kinney AY. Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial. Trials. 2013 Apr 30;14:116. doi: 10.1186/1745-6215-14-116.

Reference Type: DERIVED

PMID: 23782890 (View on PubMed)

Other Identifiers

7R01CA125194-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB_00017894

Identifier Type: -

Identifier Source: org_study_id