Improving Colon Cancer Screening for Diverse Populations

Colorectal Cancer Clinical Trial

Official title:

The CHOICES/OPCIONES Project: Improving Colon Cancer Screening for Diverse Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054598
• Other study ID #: 09-0537
• 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

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

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