Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatment decision aid and navigation
Sponsor University of North Carolina, Chapel Hill
Collaborator University of New Mexico
Start date January 2014
End date March 2016
Trial size 265 participants
Trial identifier NCT02054598, 09-0537

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.

United States New Mexico and North Dakota
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(No Intervention)
Usual care.
(Experimental)
Decision aid and navigation
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 Outcomes

Measure
Colorectal cancer screening completion
time frame: 6 months

Secondary Outcomes

Measure
Colorectal cancer screening knowledge
time frame: Post-encounter measure
Colorectal cancer screening related self-efficacy
time frame: 6 months
Colorectal cancer screening related intent
time frame: 6 months

Eligibility Criteria

Male or female participants from 50 years up to 75 years old.

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.

Additional Information

Official title The CHOICES/OPCIONES Project: Improving Colon Cancer Screening for Diverse Populations
Principal investigator Daniel Reuland, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.
Location data was received from the National Cancer Institute and was last updated in September 2016.