Study of Patient Navigation to Promote Colon Cancer Screening

Colorectal Cancer Screening Clinical Trial

Official title:

Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141114
• Other study ID #: MRSGT-05-007-01-CPPB
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: April 17, 2017
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: April 2017
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban community health centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 52 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged 52-75 who had one visit to a primary care physician in a community health center in each of the 2 previous years and who have not received colorectal cancer screening based on HEDIS criteria.

Exclusion Criteria:

• Current cancer diagnosis, undergoing treatment (or treatment completed within the past year)

• Severe cardiac disease (high-risk CAD,9 valvular disease, NYHA Class III or IV CHF, EF < 35%)

• Severe COPD (FEV1< 1liter or on home oxygen)

• CVA with severe functional impairment (aphasia or hemiparesis)

• MS with severe functional impairment

• Renal failure with CrCl< 30 or on dialysis

• Gastrointestinal symptoms (pain, bleeding, etc) within the past 6 months

• Chronic active liver disease or cirrhosis, with albumin < 3 or elevated INR

• Advanced HIV disease (CD4 count <200)

• Severe lupus (with cerebritis or renal failure as defined above)

• Severe complications of diabetes (blindness, amputations other than toes)

• Advanced Dementia

• Psychosis

• Paranoia

• Active substance abuse

• Schizophrenia

• Psychiatric hospitalization within the past year

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Other:
• Patient navigation
Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.
• Usual care
Usual care

Locations

Country	Name	City	State
United States	Cambridge Health Alliance	Cambridge	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Cambridge Health Alliance	American Cancer Society, Inc., Harvard Medical School

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lasser KE, Ayanian JZ, Fletcher RH, Good MJ. Barriers to colorectal cancer screening in community health centers: a qualitative study. BMC Fam Pract. 2008 Feb 27;9:15. doi: 10.1186/1471-2296-9-15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	completion of colorectal cancer screening		1 year
Secondary	Comparison of detection of polyps and cancers in intervention vs. control groups		1 year