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Improving Colon Cancer Screening for Diverse Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02054598
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : September 2, 2016
University of New Mexico
Atrium Health
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

This study is a multi-site randomized, controlled trial testing the effect of a combined intervention that includes a colorectal cancer (CRC) screening decision aid plus patient navigation in a diverse, primary care patient population in clinical sites in North Carolina and New Mexico.

Our primary aim is to determine the effect of the intervention on CRC screening completion six months after the index visit among all enrolled participants and among Latinos. Secondarily, we will determine how this intervention affects screening-related knowledge, self-efficacy, intent, and clinical communication, and examine whether these factors mediate the effect of the intervention on screening test completion. Lastly, we will explore whether insurance status, ethnicity, and patient language preference moderate the effect of the intervention on screening.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Decision aid and navigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The CHOICES/OPCIONES Project: Improving Colon Cancer Screening for Diverse Populations
Study Start Date : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
No Intervention: Control group
Usual care.
Experimental: Intervention group
Decision aid and navigation
Behavioral: Decision aid and navigation
Patients in the intervention group will receive a combined intervention consisting of a CRC screening decision aid and assistance from a trained patient navigator.

Primary Outcome Measures :
  1. Colorectal cancer screening completion [ Time Frame: 6 months ]
    A blinded medical record review will be used to determine the primary outcome of 6 month Colorectal cancer screening status. To ensure optimal capturing of screening test completion, we will ask participants whose medical record does not contain evidence of screening to verify non-completion during the 6 month phone survey.

Secondary Outcome Measures :
  1. Colorectal cancer screening knowledge [ Time Frame: Post-encounter measure ]
    Following the provider encounter, we will administer the post-encounter survey to measure intermediate screening related knowledge.

  2. Colorectal cancer screening related self-efficacy [ Time Frame: 6 months ]
    The Colorectal cancer screening self-efficacy will be measured by the post-encounter survey.

  3. Colorectal cancer screening related intent [ Time Frame: 6 months ]
    The post-encounter survey will be used to measure the Colorectal cancer screening related intent.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients 50 to 75 years old who are not current with colorectal cancer (CRC) screening, defined as not having completed a home fecal occult blood test (FOBT) within the past year; a flexible sigmoidoscopy within the past five years; or a colonoscopy within the past ten years.
  • Have an appointment at one of the clinic sites

Exclusion Criteria:

  • Will include: inability to speak either English or Spanish, severe illness at the time of the clinic visit, co-morbidity that is estimated to limit life-expectancy to less than 5 years as estimated by the treating nurse or provider, severe cognitive, visual, or hearing impairment that would preclude Decision Aid (DA) viewing. We will also exclude patients who are at elevated risk for CRC, defined as having ever been diagnosed with CRC, a precancerous (adenomatous) polyp, or inflammatory bowel disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02054598

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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolinas Healthcare Systems
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of New Mexico
Atrium Health
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Principal Investigator: Daniel Reuland, MD, MPH University of North Carolina

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT02054598    
Other Study ID Numbers: 09-0537
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases