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

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT01274143

Collaborator

National Cancer Institute (NCI) (NIH)

496

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: TeleCARE Behavioral: Pamphlet intervention	N/A

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.)

Study Design

Study Type:

Interventional

Actual Enrollment :

496 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Impact of Remote Familial Colorectal Cancer Assessment and Counseling

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Colonoscopy [9 month follow-up]
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) [Baseline, 1 month, 9 month, and 15 month follow-up]
Fecal occult blood test(FOBT) following the intervention. Medical confirmation of self-reported FOBT/FIT is performed.
Perceived Control [Baseline, 1 month and 9 month follow-up]
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 [Baseline, 1 month and 9 month follow-up]
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 [Baseline, 1 month and 9 month follow-up]
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 [Baseline, 1 month and 9 month follow-up]
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 [Baseline, 1 month and 9 month follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	California Cancer Registry	Sacramento	California	United States	95825
2	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
3	Colorado Central Cancer Registry	Denver	Colorado	United States	80246
4	Cancer Data Registry of Idaho	Boise	Idaho	United States	83701
5	University of New Mexico	Albuquerque	New Mexico	United States	87131
6	Intermountain Health Care	Salt Lake City	Utah	United States	84111
7	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
8	Utah Cancer Registry	Salt Lake City	Utah	United States	84112