Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations

Colorectal Cancer Clinical Trial

— AIMSS  

Official title:

Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03100461
• Other study ID #: STUDY00002929
• Secondary ID: 1R01CA188898-01A
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2020
• Source: University of Kansas Medical Center
• Contact: Angela Watson, MBA
• Phone: (913) 945-6675
• Email: awatson[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: March 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• I2
A touch screen computer delivered "implementation intentions" (I2) intervention on CRC screening. "Implementation intentions" are the exact steps (the when, what, where, how) one will take to complete a test (the date and time, at home or at the doctor's office, with what supplies, etc.).
• Health Education
Standard of care approach that will provide basic information on CRC screening.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRC screening completion rate	Rate of participants who receive CRC screening during study participation	12-14 Months
Secondary	Cost analysis of each intervention pathway	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.	14 Months