Improving Colorectal Cancer Screening for Diverse Hispanics in Urban Primary Care

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01569620
First received: March 29, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The proposed study seeks to investigate the impact of a culturally targeted print educational intervention on rates of colorectal cancer (CRC) screening via colonoscopy among Hispanics. If, as expected, the addition of culturally targeted materials to best clinical practices as compared to a) best clinical practices plus standard materials or b) best clinical practices alone leads to higher rates of CRC screening via colonoscopy then the culturally targeted print educational materials can be easily disseminated among this rapidly growing minority group who have low rates of CRC screening and whose disease is detected at later, less curable stages.


Condition Intervention
Colorectal Cancer Screening
Behavioral: Best clinical practices plus culturally targeted print materials
Behavioral: Best clinical practices plus standard print materials
Behavioral: Best clinical practices alone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Colorectal Cancer (CRC) Screening for Diverse Hispanics in an Urban Primary Care Setting

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Change from baseline of colonoscopy at 3 months, 6 months, and 12 months. [ Time Frame: Baseline, at 3 months, at 6 months, and at 12 months ] [ Designated as safety issue: No ]
    Comparison of physician recommended colonoscopy (post intervention) obtained at approximately 3 months and 6 months (via self report) and at 12 months (as per chart review), to that of colonoscopy obtained at baseline.


Estimated Enrollment: 400
Study Start Date: April 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Culturally targeted print materials
Best clinical practices plus culturally print materials
Behavioral: Best clinical practices plus culturally targeted print materials
This intervention arm includes best clinical practices (or usual care at MSSM) and the culturally relevant print materials developed for this study.
Active Comparator: Standard print materials
Best clinical practices plus standard print materials
Behavioral: Best clinical practices plus standard print materials
This intervention arm includes best clinical practices (or usual care at MSSM) and the standard CRC screening print materials developed by the Centers for Disease Control (CDC).
Active Comparator: Best clinical practices alone
Best clinical practices alone: This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.
Behavioral: Best clinical practices alone
This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.
Other Name: Usual Care

Detailed Description:

CRC is the 2nd leading cause of cancer death among Hispanic women and men. Hispanics are more likely to be diagnosed at more advanced disease stages compared to non-Hispanic whites and have a lower probability of survival. A key way to decrease mortality from CRC among Hispanics is to increase rates of CRC screening and thereby early detection of CRC. To address low screening rates, thereby increasing the prevention and early detection of CRC, the proposed research seeks to increase CRC colonoscopy screening among Hispanics. The primary aim is to investigate the impact of a culturally targeted print educational intervention designed to increase CRC screening via colonoscopy in a diverse group of Hispanics 50 years of age and older. Our long standing (since 1999) research platform has included significant community input through ongoing meetings with our Community Advisory Board (CAB) soliciting their viewpoints and concerns. In addition, we consult with key community members on an ongoing basis for additional input. A Randomized Clinical Trial (RCT) will be conducted with 400 Hispanics within the context of the best clinical practices currently provided at Mount Sinai. There are three study arms: 1) best clinical practices plus culturally relevant print materials, 2) best clinical practices plus standard print materials and 3) best clinical practices alone. These three arms will allow the investigation of the addition of print materials and the comparison of culturally relevant to standard print materials to assess the differential impact of each print format. This comparison controls for the possible benefit of adding standard print materials to best clinical practices and allows for investigation of the additional benefit of culturally targeted relevant materials over and above that of standard materials. Further, by including feedback from the community, we will be able to clearly understand the benefits of, and be able to disseminate culturally targeted materials among this rapidly growing minority group. If, as hypothesized, the addition of the culturally targeted print materials leads to higher rates of colonoscopy, they can then be easily disseminated among health care settings treating Hispanics.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identified Hispanic
  • Between the ages of 50 and 85
  • Able to provide informed consent in either English or Spanish
  • No participation in study Focus Groups by a family member or oneself
  • Referred for a screening colonoscopy by a primary care physician at Mount Sinai
  • At average risk for developing colorectal cancer
  • Have no colonoscopy procedure within the last 5 years
  • Have telephone service

Exclusion Criteria:

  • Personal history of CRC
  • Personal history of any chronic GI disorder (irritable bowel syndrome, colitis) and
  • Family history of CRC (first degree relative of CRC)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569620

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Katherine DuHamel, PhD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Lina Jandorf, MA Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01569620     History of Changes
Other Study ID Numbers: GCO 08-1159
Study First Received: March 29, 2012
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Colorectal Cancer Screening
CRC
Screening Colonoscopy
Hispanics
Latinos

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014