NCT00893295

Brief Summary

RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to treat. Finding out what affects a patient's decision to undergo screening tests may help increase the number of patients who undergo regular screening for cancer. It is not yet known whether personalized invitations to undergo colorectal cancer screening are more effective than standard screening reminders. PURPOSE: This randomized phase III trial is studying ways to increase colorectal cancer screening in African Americans.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
896

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

February 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

December 18, 2013

Status Verified

July 1, 2009

Enrollment Period

3.8 years

First QC Date

May 2, 2009

Last Update Submit

December 17, 2013

Conditions

Keywords

colon cancerrectal cancer

Outcome Measures

Primary Outcomes (1)

  • Intervention impact on colorectal cancer (CRC) screening utilization over the 6-month observation period

Secondary Outcomes (2)

  • Intervention impact on CRC screening preference, based on data obtained from both the endpoint chart audit and the endpoint survey

  • Intervention impact on population health-management representations related to CRC screening, as assessed by perceived salience and coherence and self-efficacy-related CRC screening measured with 6 to 10 Likert-type items on both the baseline and end ...

Interventions

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * African-American participants who receive medical care in a large, urban primary care practice setting and are eligible for colorectal cancer (CRC) screening * Noncompliant with CRC screening in terms of American Cancer Society guidelines * Attended an office visit within the past 2 years PATIENT CHARACTERISTICS: * No family history of colorectal cancer diagnosed before the age of 60 years * No prior diagnosis of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease PRIOR CONCURRENT THERAPY: * Not specified

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

Barium EnemaSigmoidoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FluoroscopyRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisEnemaDrug TherapyTherapeuticsColonoscopyEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Ronald Myers, PhD

    Jefferson Medical College of Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2009

First Posted

May 5, 2009

Study Start

February 1, 2008

Primary Completion

December 1, 2011

Last Updated

December 18, 2013

Record last verified: 2009-07

Locations