NCT00818857

Brief Summary

The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,072

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

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

January 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

3.8 years

First QC Date

January 6, 2009

Last Update Submit

June 16, 2016

Conditions

Keywords

cancer screeningscreening disparitiesunderserved populations

Outcome Measures

Primary Outcomes (1)

  • To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome.

    End of project, 12/2011

Study Arms (2)

1

ACTIVE COMPARATOR

Early intervention.

Behavioral: Early Intervention

2

ACTIVE COMPARATOR

Delayed intervention

Behavioral: Delayed intervention

Interventions

At the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests.

1

One year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests.

2

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men age 50-75 yrs.
  • Women age 40-75 yrs
  • One primary care visit in past 2 years.

You may not qualify if:

  • High risk for colorectal or breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fiscella K, Humiston S, Hendren S, Winters P, Idris A, Li SX, Ford P, Specht R, Marcus S. A multimodal intervention to promote mammography and colorectal cancer screening in a safety-net practice. J Natl Med Assoc. 2011 Aug;103(8):762-8. doi: 10.1016/s0027-9684(15)30417-x.

  • Fiscella K, Yosha A, Hendren SK, Humiston S, Winters P, Ford P, Loader S, Specht R, Pope S, Adris A, Marcus S. Get screened: a pragmatic randomized controlled trial to increase mammography and colorectal cancer screening in a large, safety net practice. BMC Health Serv Res. 2010 Sep 23;10:280. doi: 10.1186/1472-6963-10-280.

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Kevin Fiscella, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 8, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2012

Study Completion

February 1, 2013

Last Updated

June 20, 2016

Record last verified: 2016-06