NCT01299493

Brief Summary

Colorectal cancer is the second leading cause of cancer death and one of the most commonly diagnosed malignancies. Screening is effective at reducing incidence and mortality from colorectal cancer. This study will evaluate the effectiveness of implementing systems-changes in community health centers that facilitate screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
490

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 19, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2017

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

5.3 years

First QC Date

February 16, 2011

Last Update Submit

July 11, 2018

Conditions

Keywords

carcinomacolorectal cancercommunity health centerscluster-randomizedhealth behavior

Outcome Measures

Primary Outcomes (1)

  • Practice-level colon cancer screening rate

    Colorectal cancer screening will be assessed as the proportion of screening-eligible patients who are adherent to national screening guidelines for colorectal cancer.

    12-months post baseline

Study Arms (2)

Interventional

EXPERIMENTAL

Access to systems-level interventions to increase colorectal cancer screening.

Other: Systems-level intervention to promote colon cancer screening

Usual Care

NO INTERVENTION

Practices will receive access to intervention components after outcomes data collection is complete.

Interventions

Intervention practices will receive access to, and assistance in implementing, evidence-based strategies for increasing colorectal cancer screening rates.

Interventional

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Community health center in the Saint Louis Metropolitan Area, including Southern Illinois
  • Participant in Partnership Planning Process
  • Affiliated with the Washington University Program for the Elimination of Cancer Disparities

You may not qualify if:

  • Primary patient population has private health insurance.
  • Not in an medically underserved area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • James AS, Richardson V, Wang JS, Proctor EK, Colditz GA. Systems intervention to promote colon cancer screening in safety net settings: protocol for a community-based participatory randomized controlled trial. Implement Sci. 2013 Jun 3;8:58. doi: 10.1186/1748-5908-8-58.

Related Links

MeSH Terms

Conditions

CarcinomaColorectal NeoplasmsHealth Behavior

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Study Officials

  • Aimee S James, PhD, MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 18, 2011

Study Start

June 19, 2012

Primary Completion

September 21, 2017

Study Completion

September 21, 2017

Last Updated

July 12, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations