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


N/A
50 Years
85 Years
Open (Enrolling by invite only)
Both
Colorectal Cancer Screening

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Change from baseline of colonoscopy at 3 months, 6 months, and 12 months.

Outcome 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.

Outcome Time Frame:

Baseline, at 3 months, at 6 months, and at 12 months

Safety Issue:

No

Principal Investigator

Katherine DuHamel, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

GCO 08-1159

NCT ID:

NCT01569620

Start Date:

April 2012

Completion Date:

August 2017

Related Keywords:

  • Colorectal Cancer Screening
  • Colorectal Cancer Screening
  • CRC
  • Screening Colonoscopy
  • Hispanics
  • Latinos
  • Colorectal Neoplasms

Name

Location

Icahn School of Medicine at Mount Sinai New York, New York  10029