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Improving Colon Cancer Screening for Diverse Populations

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Colorectal Cancer

Treatments

Behavioral: Decision aid and navigation

Study type

Interventional

Funder types

Other

Identifiers

NCT02054598
09-0537

Details and patient eligibility

About

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.

Enrollment

265 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

265 participants in 2 patient groups

Control group
No Intervention group
Description:
Usual care.
Intervention group
Experimental group
Description:
Decision aid and navigation
Treatment:
Behavioral: Decision aid and navigation

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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