NCT00617071

Brief Summary

RATIONALE: Developing a personalized screening plan may be more effective than usual care in increasing the number of healthy participants who regularly undergo screening for colorectal cancer. PURPOSE: This randomized phase III trial is studying personalized screening plans to see how well they work compared with usual care in increasing colorectal cancer screening in healthy participants.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

December 18, 2013

Status Verified

July 1, 2009

Enrollment Period

3.9 years

First QC Date

February 14, 2008

Last Update Submit

December 17, 2013

Conditions

Keywords

colon cancerrectal cancer

Outcome Measures

Primary Outcomes (1)

  • Screening utilization over the 6-month observation period

Secondary Outcomes (4)

  • Screening preference

  • Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening

  • Number and length of contacts with each participant and the type of communication during those contacts

  • Identification of predictors of CRC screening use and screening preference

Interventions

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets the following criteria: * No personal history of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease * No family history of colorectal cancer (CRC) diagnosed before the age of 60 * Visited one of the six community-based primary care practices that are part of the Christiana Care Health System (CCHS) in Delaware within the past 2 years * Not up-to-date with CRC screening, according to the United States Preventive Services Task Force guidelines PATIENT CHARACTERISTICS: * Must have a complete address and telephone number * Able to communicate in English * No psychosis or severe dementia PRIOR CONCURRENT THERAPY: * No prior participation in the developmental study CA10241

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

Sponsors & Collaborators

Study Sites (1)

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Occult Blood

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Ronald Myers, PhD

    Jefferson Medical College of Thomas Jefferson University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
HEALTH SERVICES RESEARCH
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 15, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Last Updated

December 18, 2013

Record last verified: 2009-07

Locations