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Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal Cancer, Cancer Screening, Patient Navigation, Low English Proficiency

Eligibility Criteria

52 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between 52-79 years of age
  • Have not had a colonoscopy within the last 10 years
  • Have not had a sigmoidoscopy/barium enema within the past 5 years
  • Have not had a home fecal occult blood testing within the past year.

Exclusion Criteria:

  • Acutely ill
  • Dementia
  • Metastatic cancer
  • Schizophrenia
  • Any end stage disease

Sites / Locations

  • MGH Chelsea Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Navigation Intervention

Usual Care

Arm Description

Participants randomized to this arm will receive language-concordant patient navigation in the form of an introductory letter with educational material followed by phone or in-person contact to provide individually tailored interventions.

Participants randomized to this arm will receive no additional navigation beyond the usual care for the duration of the 9-month intervention. Participants will be offered navigation services after the completion of the intervention period.

Outcomes

Primary Outcome Measures

Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening

Secondary Outcome Measures

Type of CRC Screening Test Performed in Study vs Control Groups
Number of Polyps and Cancers per 100 Patients in the Study vs Control Group

Full Information

First Posted
May 21, 2007
Last Updated
September 20, 2016
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00476970
Brief Title
Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations
Official Title
Improving Colorectal Cancer Screening Rates by Lowering Barriers in Low Income and Non-English Speaking Populations: The Chelsea Colorectal Cancer Screening Project
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to implement and in a controlled randomised trial test a program to identify and overcome barriers to CRC screening and thus improve CRC screening rates at MGH Chelsea HC. Our hypothesis is that a bilingual navigator program, enhanced by using trained interpreting staff will improve CRC screening rates at MGH Chelsea HC overall, and decrease disparities between patients with limited English proficiency and English speakers
Detailed Description
We developed a training program for five health center interpreters fluent in eight different languages. Patients randomly assigned to the study intervention receive an introductory letter in their native language. During the initial contact the navigator educates patients about CRC screening and explores patients' barriers to CRC screening. Based on results from a qualitative study conducted at in 2006, we developed interventions to overcome individual barriers to CRC screening tailored to each individual patient. Specific interventions include elucidation of culturally-specific health beliefs; teaching about cancer risk, colonoscopy, and colon prep administration; and help with appointment-making and transport.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, Cancer Screening, Patient Navigation, Low English Proficiency

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Navigation Intervention
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive language-concordant patient navigation in the form of an introductory letter with educational material followed by phone or in-person contact to provide individually tailored interventions.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will receive no additional navigation beyond the usual care for the duration of the 9-month intervention. Participants will be offered navigation services after the completion of the intervention period.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Intervention Description
Patient navigators will perform an initial interview with participants to identify and explore barriers, work with patients to overcome barriers, educate patients about CRC screening, motivate and coach patients, and schedule and accompany patients to colonoscopy testing
Primary Outcome Measure Information:
Title
Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening
Time Frame
18 Months
Secondary Outcome Measure Information:
Title
Type of CRC Screening Test Performed in Study vs Control Groups
Time Frame
18 Months
Title
Number of Polyps and Cancers per 100 Patients in the Study vs Control Group
Time Frame
18 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
52 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 52-79 years of age Have not had a colonoscopy within the last 10 years Have not had a sigmoidoscopy/barium enema within the past 5 years Have not had a home fecal occult blood testing within the past year. Exclusion Criteria: Acutely ill Dementia Metastatic cancer Schizophrenia Any end stage disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanja Percac-Lima, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Chelsea Health Center
City
Chelsea
State/Province
Massachusetts
ZIP/Postal Code
02150
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19067085
Citation
Percac-Lima S, Grant RW, Green AR, Ashburner JM, Gamba G, Oo S, Richter JM, Atlas SJ. A culturally tailored navigator program for colorectal cancer screening in a community health center: a randomized, controlled trial. J Gen Intern Med. 2009 Feb;24(2):211-7. doi: 10.1007/s11606-008-0864-x.
Results Reference
derived

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Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations

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