Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities

NCT ID: NCT00818857

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1072 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-02-28

Brief Summary

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

Detailed Description

This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.

Conditions

Preventive Measures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Early intervention.

Group Type: ACTIVE_COMPARATOR

Early Intervention

Intervention Type: BEHAVIORAL

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

2

Delayed intervention

Group Type: ACTIVE_COMPARATOR

Delayed intervention

Intervention Type: BEHAVIORAL

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

Interventions

Early Intervention

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

Intervention Type: BEHAVIORAL

Delayed intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• High risk for colorectal or breast cancer.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kevin Fiscella

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Fiscella, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

References

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.

Reference Type: DERIVED

PMID: 22046855 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20863395 (View on PubMed)

Other Identifiers

RSRB 00025557

Identifier Type: -

Identifier Source: org_study_id