NCT00476970

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,223

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

May 21, 2007

Last Update Submit

September 20, 2016

Conditions

Colorectal Cancer

Keywords

Colorectal CancerCancer ScreeningPatient NavigationLow English Proficiency

Outcome Measures

Primary Outcomes (1)

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

    18 Months

Secondary Outcomes (2)

  • Type of CRC Screening Test Performed in Study vs Control Groups

    18 Months

  • Number of Polyps and Cancers per 100 Patients in the Study vs Control Group

    18 Months

Study Arms (2)

Patient Navigation Intervention

EXPERIMENTAL

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.

Behavioral: Patient Navigation

Usual Care

NO INTERVENTION

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.

Interventions

Patient NavigationBEHAVIORAL

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

Patient Navigation Intervention

Eligibility Criteria

Age52 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Chelsea Health Center

Chelsea, Massachusetts, 02150, United States

Location

Related Publications (1)

  • 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.

    PMID: 19067085DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Sanja Percac-Lima, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 21, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)