Skip to main content
OpenTrials
Completed

NCT Number: NCT01569620

Improving Colorectal Cancer Screening for Diverse Hispanics in Urban Primary Care

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Best clinical practices plus culturally targeted print materials

Behavioral

This intervention arm includes best clinical practices (or usual care at MSSM) and the culturally relevant print materials developed for this study.

Best clinical practices plus standard print materials

Behavioral

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).

Best clinical practices alone

Behavioral

This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.

Other names: Usual Care

Primary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center

Registry information

Official study title

Improving Colorectal Cancer (CRC) Screening for Diverse Hispanics in an Urban Primary Care Setting

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2012
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.