Study of Patient Navigation to Promote Colon Cancer Screening

NCT01141114 | Completed

• 1 other identifier: MRSGT-05-007-01-CPPB
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer Screening

Keywords

community health centers; colorectal cancer screening; urban health

Outcome Measures

Primary Outcomes (1)

• completion of colorectal cancer screening

  1 year

Secondary Outcomes (1)

• Comparison of detection of polyps and cancers in intervention vs. control groups

  1 year

Study Arms (2)

Use of a Patient Navigator

EXPERIMENTAL

Other: Patient navigation

Usual Care

OTHER

No Intervention - usual care

Other: Usual care

Interventions

Patient navigation OTHER

Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.

Use of a Patient Navigator

Usual care OTHER

Usual care

Usual Care

Eligibility Criteria

• Age: 52 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• American Cancer Society, Inc.: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (2)

• 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.

  PMID: 18304342 BACKGROUND

• Lasser KE, Murillo J, Lisboa S, Casimir AN, Valley-Shah L, Emmons KM, Fletcher RH, Ayanian JZ. Colorectal cancer screening among ethnically diverse, low-income patients: a randomized controlled trial. Arch Intern Med. 2011 May 23;171(10):906-12. doi: 10.1001/archinternmed.2011.201.

  PMID: 21606094 DERIVED

MeSH Terms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Karen E Lasser, MD, MPH

  Cambridge Health Alliance/Harvard Medical School

  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: June 9, 2010
• First Posted: June 10, 2010
• Study Start: September 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)