NCT00955188

Brief Summary

RATIONALE: A computer program that provides information on colorectal cancer screening based on a patient's test preferences may be more effective than a computer program that gives standard information in helping patients get regular colorectal cancer screenings. PURPOSE: This randomized clinical trial is studying computer-based tailored information to see how well it works compared with standard information for colorectal cancer screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2004

Typical duration for all trials

Geographic Reach
1 country

3 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

August 1, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

2.7 years

First QC Date

August 7, 2009

Last Update Submit

December 19, 2012

Conditions

Colorectal Cancer

Keywords

colon cancerrectal cancer

Outcome Measures

Primary Outcomes (1)

  • Adherence to colorectal cancer screening at 12 months post-intervention

    12 months

Secondary Outcomes (4)

  • Elements of informed decision making

    12 months

  • Knowledge about screening options

    12 months

  • Decisional conflict and satisfaction

    12 months

  • Intention to get screened

    12 months

Interventions

computer-assisted interventionOTHER
educational interventionOTHER
medical chart reviewOTHER

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Kelsey-Seybold Clinic, Houston, Tx Study Coordinator: Bettencourt , Judy ( ) Email: Judith.L.Bettencourt@uth.tmc.e Phone: 713-500-9754

DISEASE CHARACTERISTICS: * At average risk for colorectal cancer (CRC), defined as the following: * No personal history of CRC, adenomatous colon polyps, or inflammatory bowel disease * No family history of CRC * Not up-to-date with CRC screening in past year OR have never been screened, defined as * Up-to-date screening is defined as having completed 1 of the following: * Fecal occult blood test within the past 2 years * Sigmoidoscopy within the past 5 years * Colonoscopy with the past 10 years * Double-contrast barium enema within the past 5 years * Patient at San Francisco Community Health Network or at Henry Ford Health System and a member of the Health Alliance Plan PATIENT CHARACTERISTICS: * Life expectancy ≥ 1 year * No history of inflammatory bowel disease, polyposis, or hereditary nonpolyposis * No severe comorbidity or significantly lowered life expectancy, including any of the following: * Do not resuscitate (DNR)/do not intubate (DNI) code status * Metastatic cancer * End-stage congestive heart failure * Severe chronic obstructive pulmonary disease * Coronary artery disease with recent myocardial infarction or unstable angina * Dementia PRIOR CONCURRENT THERAPY: * No prior bowel resection

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Sarah T. Hawley, PhD, MPH

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 10, 2009

Study Start

August 1, 2004

Primary Completion

April 1, 2007

Study Completion

May 1, 2008

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations

US(3)