Phase 3 N=566 Randomized Single-blind Health Services Research

Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01103479 ↗

Enrolled (actual)

566

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Colorectal Cancer (CRC) Screening Completion — 17; 69 participants — p=0.32

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Physician Intervention (Behavioral); Physician and Patient Intervention (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Colorectal Cancer (CRC) Screening Completion	41; 28	0.28
PRIMARY Colorectal Cancer (CRC) Screening Completion	41; 28	0.28
SECONDARY Provider Recommendation of CRC Screening	113; 103	0.38

Summary

The purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (CRC) screening among the medically underserved.

Eligibility Criteria

Inclusion Criteria

Patients aged 50-75 years of age (in month 1 of the study)
Patients have had two or more visits to the clinic during the past two years
ACCESS Community Health Network patients
University of Illinois Hospital & Health Sciences System patients
Patients ages 50 - 75 as of the start of the intervention study
English or Spanish-Speaking

Exclusion Criteria

Patients 75 years of age
Patients who have had fewer than two or more visits to the clinic during the past two years
Personal history of CRC or colorectal polyps, or of inflammatory bowel disease and a family history with a first-degree relative with CRC or colorectal polyps.
Unable to speak English or Spanish
Compliant with CRC screening (FOBT or FIT within the past year; flexible sigmoidoscopy within past 5 years; colonoscopy within past 10 years)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01103479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.