Clinical trial NCT02054598: Improving Colon Cancer Screening for Diverse Populations
Official title: The CHOICES/OPCIONES Project: Improving Colon Cancer Screening for Diverse Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: Wake Forest University Health Sciences
First posted: 2014-02-04
Enrollment: 265
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Colorectal cancer screening completion
timeFrame: 6 months
Secondary outcomes:
measure: Colorectal cancer screening knowledge
timeFrame: Post-encounter measure
measure: Colorectal cancer screening related self-efficacy
timeFrame: 6 months
measure: Colorectal cancer screening related intent
timeFrame: 6 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Healthcare Systems
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Daniel Reuland, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reuland DS, Brenner AT, Hoffman R, McWilliams A, Rhyne RL, Getrich C, Tapp H, Weaver MA, Callan D, Cubillos L, Urquieta de Hernandez B, Pignone MP. Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):967-974. doi: 10.1001/jamainternmed.2017.1294.
citation: Brenner AT, Hoffman R, McWilliams A, Pignone MP, Rhyne RL, Tapp H, Weaver MA, Callan D, de Hernandez BU, Harbi K, Reuland DS. Colorectal Cancer Screening in Vulnerable Patients: Promoting Informed and Shared Decisions. Am J Prev Med. 2016 Oct;51(4):454-62. doi: 10.1016/j.amepre.2016.03.025. Epub 2016 May 27.
citation: Brenner AT, Getrich CM, Pignone M, Rhyne RL, Hoffman RM, McWilliams A, de Hernandez BU, Weaver MA, Tapp H, Harbi K, Reuland D. Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial. Trials. 2014 Jul 8;15:275. doi: 10.1186/1745-6215-15-275.