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Study of Patient Navigation to Promote Colon Cancer Screening

Primary Purpose

Colorectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient navigation
Usual care
Sponsored by
Cambridge Health Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Screening focused on measuring community health centers, colorectal cancer screening, urban health

Eligibility Criteria

52 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cambridge Health Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Use of a Patient Navigator

Usual Care

Arm Description

No Intervention - usual care

Outcomes

Primary Outcome Measures

completion of colorectal cancer screening

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2010
Last Updated
April 17, 2017
Sponsor
Cambridge Health Alliance
Collaborators
American Cancer Society, Inc., Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT01141114
Brief Title
Study of Patient Navigation to Promote Colon Cancer Screening
Official Title
Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cambridge Health Alliance
Collaborators
American Cancer Society, Inc., Harvard Medical School (HMS and HSDM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
community health centers, colorectal cancer screening, urban health

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
465 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of a Patient Navigator
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Other
Arm Description
No Intervention - usual care
Intervention Type
Other
Intervention Name(s)
Patient navigation
Intervention Description
Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
completion of colorectal cancer screening
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Comparison of detection of polyps and cancers in intervention vs. control groups
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
52 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen E Lasser, MD, MPH
Organizational Affiliation
Cambridge Health Alliance/Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18304342
Citation
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.
Results Reference
background
PubMed Identifier
21606094
Citation
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.
Results Reference
derived

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Study of Patient Navigation to Promote Colon Cancer Screening

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