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Improving Colon Cancer Screening for Diverse Populations

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ClinicalTrials.gov Identifier: NCT02054598
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : September 2, 2016
Sponsor:
Collaborators:
University of New Mexico
Atrium Health
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE January 31, 2014
First Posted Date  ICMJE February 4, 2014
Last Update Posted Date September 2, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
Colorectal cancer screening completion [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT02054598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • 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.
  • Colorectal cancer screening related self-efficacy [ Time Frame: 6 months ]
    The Colorectal cancer screening self-efficacy will be measured by the post-encounter survey.
  • Colorectal cancer screening related intent [ Time Frame: 6 months ]
    The post-encounter survey will be used to measure the Colorectal cancer screening related intent.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
  • Colorectal cancer screening knowledge [ Time Frame: 6 months ]
  • Colorectal screening related self-efficacy [ Time Frame: 6 months ]
  • Colorectal cancer screening related intent [ Time Frame: 6 months ]
  • Colorectal cancer screening related clinical communication [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Colon Cancer Screening for Diverse Populations
Official Title  ICMJE The CHOICES/OPCIONES Project: Improving Colon Cancer Screening for Diverse Populations
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: Control group
    Usual care.
  • Experimental: Intervention group
    Decision aid and navigation
    Intervention: Behavioral: Decision aid and navigation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2016)
265
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2014)
300
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02054598
Other Study ID Numbers  ICMJE 09-0537
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • University of New Mexico
  • Atrium Health
Investigators  ICMJE
Principal Investigator: Daniel Reuland, MD, MPH University of North Carolina
PRS Account University of North Carolina, Chapel Hill
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP