Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations
September 20, 2016 updated by: Sanja Percac-Lima, MD, Massachusetts General Hospital
Improving Colorectal Cancer Screening Rates by Lowering Barriers in Low Income and Non-English Speaking Populations: The Chelsea Colorectal Cancer Screening Project
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1223
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Chelsea, Massachusetts, United States, 02150
- MGH Chelsea Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
52 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Patient Navigation Intervention
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.
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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
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No Intervention: Usual Care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening
Time Frame: 18 Months
|
18 Months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Type of CRC Screening Test Performed in Study vs Control Groups
Time Frame: 18 Months
|
18 Months
|
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Number of Polyps and Cancers per 100 Patients in the Study vs Control Group
Time Frame: 18 Months
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18 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanja Percac-Lima, MD, PhD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
May 21, 2007
First Submitted That Met QC Criteria
May 21, 2007
First Posted (Estimate)
May 22, 2007
Study Record Updates
Last Update Posted (Estimate)
September 21, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006P 002254
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.