Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: I2; Other: Health Education

• Registration Number: NCT03100461
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The goal of this study is to find the best ways to increase colorectal cancer (CRC) screening.

Detailed Description

Colorectal Cancer is preventable and curable but is still the second most common cause of cancer death in the U.S. Minorities and those with low income have more CRC than middle and high income Whites.. They also get fewer CRC screening tests. Low knowledge of CRC screening may, in part, drive this lower test use. We need new ways to improve CRC screening in primary care clinics where many minority and uninsured patients receive health care.

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Study Start: 2018-01-22
• Status Verified: 2020-05
• Primary Completion: 2022-08-31
• Study Completion: 2022-09-30
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Have a home address and access to a working telephone
• Pass Mini-Cog assessment

Exclusion Criteria

• FIT (fecal immunochemical test) test within 1 year, Sigmoidoscopy or Barium enema within 5 years, or Colonoscopy within 10 years
• Acute medical illness,
• current GI bleed
• history of adenomatous polyps
• Colorectal Cancer
• 1st degree relative with CRC < age 60 years
• inherited polyposis/non-polyposis syndrome
• inflammatory bowel disease
• Another household member enrolled in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I2 + HE	Health Education	Participants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months.
HE + I2	Health Education	Participants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months.
I2 + HE	I2	Participants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months.
HE + HE	Health Education	Participants receive up to two interventions. Participants receive HE initially and then a second time if not screened after 6 months.
HE + I2	I2	Participants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months.
I2 + I2	I2	Participants receive up to two interventions. Participants receive I2 initially and then a second time if not screened after 6 months.

Primary Outcome Measures

Name	Time	Method
CRC screening completion rate	12-14 Months	Rate of participants who receive CRC screening during study participation

Secondary Outcome Measures

Name	Time	Method
Cost analysis of each intervention pathway	14 Months	Measure will be calculated by estimating all cost factors in the CRC screening process, include personnel and materials/supplies costs, materials development costs, and time of all study staff involved. Measure represented as a per participant cost to complete screening.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States