Clinical trial NCT01274143: Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project)
Official title: Impact of Remote Familial Colorectal Cancer Assessment and Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal
Cancer
Colon
Rectal
Behavioral Intervention
Screening
Motivational Interviewing
Extended Parallel Process Model
Implementation Intentions
Family CARE
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-01-11
Enrollment: 496
Sex: ALL
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.)

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.

Primary outcomes:
measure: Colonoscopy
timeFrame: 9 month follow-up
Secondary outcomes:
measure: Fecal occult blood test (FOBT)/Fecal Immunochemical Test (FIT)
timeFrame: Baseline, 1 month, 9 month, and 15 month follow-up
measure: Perceived Control
timeFrame: Baseline, 1 month and 9 month follow-up
measure: Perceived Risk
timeFrame: Baseline, 1 month and 9 month follow-up
measure: Psychological distress
timeFrame: Baseline, 1 month and 9 month follow-up
measure: Knowledge
timeFrame: Baseline, 1 month and 9 month follow-up
measure: Decisional Conflict
timeFrame: Baseline, 1 month and 9 month follow-up
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: California Cancer Registry
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Denver
country: United States
facility: Colorado Central Cancer Registry
state: Colorado
city: Boise
country: United States
facility: Cancer Data Registry of Idaho
state: Idaho
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Salt Lake City
country: United States
facility: Intermountain Health Care
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Registry
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute and University of Utah
name: Anita Y Kinney, Ph.D., R.N.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.