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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02054598
Other study ID # 09-0537
Secondary ID
Status Completed
Phase N/A
First received January 31, 2014
Last updated September 1, 2016
Start date January 2014
Est. completion date March 2016

Study information

Verified date September 2016
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 265
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 75 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States 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

Sponsors (3)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Carolinas Healthcare System, University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Colorectal cancer screening completion 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. 6 months No
Secondary Colorectal cancer screening knowledge Following the provider encounter, we will administer the post-encounter survey to measure intermediate screening related knowledge. Post-encounter measure No
Secondary Colorectal cancer screening related self-efficacy The Colorectal cancer screening self-efficacy will be measured by the post-encounter survey. 6 months No
Secondary Colorectal cancer screening related intent The post-encounter survey will be used to measure the Colorectal cancer screening related intent. 6 months No
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