NCT01274143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
496

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 8, 2016

Status Verified

May 1, 2015

Enrollment Period

4.9 years

First QC Date

December 10, 2010

Last Update Submit

April 6, 2016

Conditions

Colorectal Cancer

Keywords

ColorectalCancerColonRectalBehavioral InterventionScreeningMotivational InterviewingExtended Parallel Process ModelImplementation IntentionsFamily CARE

Outcome Measures

Primary Outcomes (1)

  • Colonoscopy

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

    9 month follow-up

Secondary Outcomes (6)

  • Fecal occult blood test (FOBT)/Fecal Immunochemical Test (FIT)

    Baseline, 1 month, 9 month, and 15 month follow-up

  • Perceived Control

    Baseline, 1 month and 9 month follow-up

  • Perceived Risk

    Baseline, 1 month and 9 month follow-up

  • Psychological distress

    Baseline, 1 month and 9 month follow-up

  • Knowledge

    Baseline, 1 month and 9 month follow-up

  • +1 more secondary outcomes

Study Arms (2)

Telephone-delivered risk intervention

ACTIVE COMPARATOR

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

Behavioral: TeleCARE

Mailed pamphlet intervention group

ACTIVE COMPARATOR

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

Behavioral: Pamphlet intervention

Interventions

TeleCAREBEHAVIORAL

Personalized telephone-delivered cancer risk assessment.

Telephone-delivered risk intervention
Pamphlet interventionBEHAVIORAL

Mailed pamphlet about familial colorectal cancer risk and screening.

Mailed pamphlet intervention group

Eligibility Criteria

Age30 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

California Cancer Registry

Sacramento, California, 95825, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Colorado Central Cancer Registry

Denver, Colorado, 80246, United States

Location

Cancer Data Registry of Idaho

Boise, Idaho, 83701, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Intermountain Health Care

Salt Lake City, Utah, 84111, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Utah Cancer Registry

Salt Lake City, Utah, 84112, United States

Location

Related Publications (4)

  • 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.

    PMID: 28236077DERIVED

  • 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.

    PMID: 24435063DERIVED

  • 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.

    PMID: 24307472DERIVED

  • 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.

    PMID: 23782890DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasms

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Anita Y Kinney, Ph.D., R.N.

    Huntsman Cancer Institute and University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2010

First Posted

January 11, 2011

Study Start

May 1, 2008

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 8, 2016

Record last verified: 2015-05

Locations

US(8)