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Improving Colorectal Cancer Screening for Diverse Hispanics in Urban Primary Care

Primary Purpose

Colorectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best clinical practices plus culturally targeted print materials
Best clinical practices plus standard print materials
Best clinical practices alone
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer Screening focused on measuring Colorectal Cancer Screening, CRC, Screening Colonoscopy, Hispanics, Latinos

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Culturally targeted print materials

Standard print materials

Best clinical practices alone

Arm Description

Best clinical practices plus culturally print materials

Best clinical practices plus standard print materials

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

Outcomes

Primary Outcome Measures

Change from baseline of colonoscopy at 3 months, 6 months, and 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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2012
Last Updated
January 28, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01569620
Brief Title
Improving Colorectal Cancer Screening for Diverse Hispanics in Urban Primary Care
Official Title
Improving Colorectal Cancer (CRC) Screening for Diverse Hispanics in an Urban Primary Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Memorial Sloan Kettering Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
Colorectal Cancer Screening, CRC, Screening Colonoscopy, Hispanics, Latinos

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
386 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Culturally targeted print materials
Arm Type
Active Comparator
Arm Description
Best clinical practices plus culturally print materials
Arm Title
Standard print materials
Arm Type
Active Comparator
Arm Description
Best clinical practices plus standard print materials
Arm Title
Best clinical practices alone
Arm Type
Active Comparator
Arm Description
Best clinical practices alone: This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.
Intervention Type
Behavioral
Intervention Name(s)
Best clinical practices plus culturally targeted print materials
Intervention Description
This intervention arm includes best clinical practices (or usual care at MSSM) and the culturally relevant print materials developed for this study.
Intervention Type
Behavioral
Intervention Name(s)
Best clinical practices plus standard print materials
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Best clinical practices alone
Other Intervention Name(s)
Usual Care
Intervention Description
This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.
Primary Outcome Measure Information:
Title
Change from baseline of colonoscopy at 3 months, 6 months, and 12 months.
Description
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.
Time Frame
Baseline, at 3 months, at 6 months, and at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine DuHamel, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lina Jandorf, MA
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30302744
Citation
Cotter G, DuHamel K, Schofield E, Jandorf L. Processes of Change for Colonoscopy: Limited Support for Use Among Navigated Latinos. J Racial Ethn Health Disparities. 2019 Apr;6(2):327-334. doi: 10.1007/s40615-018-0528-4. Epub 2018 Oct 9.
Results Reference
derived

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Improving Colorectal Cancer Screening for Diverse Hispanics in Urban Primary Care

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