Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations (AIMSS)

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Health Education; Other: I2

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 Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HE + HE; Participants receive up to two interventions. Participants receive HE initially and then a second time if not screened after 6 months.	Other: Health Education; Standard of care approach that will provide basic information on CRC screening.
Active Comparator: HE + I2; Participants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months.	Other: Health Education; Standard of care approach that will provide basic information on CRC screening.; 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.).; Other Names: Implementation Intentions
Experimental: I2 + I2; Participants receive up to two interventions. Participants receive I2 initially and then a second time if not screened after 6 months.	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.).; Other Names: Implementation Intentions
Active Comparator: I2 + HE; Participants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months.	Other: Health Education; Standard of care approach that will provide basic information on CRC screening.; 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.).; Other Names: Implementation Intentions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC screening completion rate	Rate of participants who receive CRC screening during study participation	12-14 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Allen Greiner, MD, MPH, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Colon Cancer; Cancer Screening; Colon Cancer Screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: STUDY00002929; 1R01CA188898-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No