Improving Colon Cancer Screening for Diverse Populations

Not Applicable

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT02054598
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Colorectal cancer screening completion	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

Name	Time	Method
Colorectal cancer screening knowledge	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	6 months	The Colorectal cancer screening self-efficacy will be measured by the post-encounter survey.
Colorectal cancer screening related intent	6 months	The post-encounter survey will be used to measure the Colorectal cancer screening related intent.

Trial Locations

Locations (3)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Carolinas Healthcare Systems; 🇺🇸 Charlotte, North Carolina, United States