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OpenTrials
Completed

NCT Number: NCT01141114

Study of Patient Navigation to Promote Colon Cancer Screening

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.

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Key information

Conditions

Colorectal Cancer Screening

Age range

52 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation

Other

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

Usual Care

Other

Usual care

Primary outcomes

  1. completion of colorectal cancer screening

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Collaborators

  • American Cancer Society, Inc.
  • Harvard Medical School (HMS and HSDM)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2010
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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