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

Colorectal Cancer Clinical Trial

Official title:

Improving Colorectal Cancer Screening Rates by Lowering Barriers in Low Income and Non-English Speaking Populations: The Chelsea Colorectal Cancer Screening Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476970
• Other study ID #: 2006P 002254
• Status: Completed
• Phase: N/A
• First received: May 21, 2007
• Last updated: September 20, 2016
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1223
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 52 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Patient Navigation
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

Locations

Country	Name	City	State
United States	MGH Chelsea Health Center	Chelsea	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening		18 Months	No
Secondary	Type of CRC Screening Test Performed in Study vs Control Groups		18 Months	No
Secondary	Number of Polyps and Cancers per 100 Patients in the Study vs Control Group		18 Months	No