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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
I2
Health Education
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Cancer Screening, Colon Cancer, Colon Cancer Screening

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Active Comparator

Arm Label

HE + HE

HE + I2

I2 + I2

I2 + HE

Arm Description

Participants receive up to two interventions. Participants receive HE initially and then a second time if not screened after 6 months.

Participants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months.

Participants receive up to two interventions. Participants receive I2 initially and then a second time if not screened after 6 months.

Participants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months.

Outcomes

Primary Outcome Measures

CRC screening completion rate
Rate of participants who receive CRC screening during study participation

Secondary Outcome Measures

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.

Full Information

First Posted
March 29, 2017
Last Updated
March 12, 2020
Sponsor
University of Kansas Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03100461
Brief Title
Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
Acronym
AIMSS
Official Title
Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Cancer Screening, Colon Cancer, Colon Cancer Screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HE + HE
Arm Type
Active Comparator
Arm Description
Participants receive up to two interventions. Participants receive HE initially and then a second time if not screened after 6 months.
Arm Title
HE + I2
Arm Type
Active Comparator
Arm Description
Participants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months.
Arm Title
I2 + I2
Arm Type
Experimental
Arm Description
Participants receive up to two interventions. Participants receive I2 initially and then a second time if not screened after 6 months.
Arm Title
I2 + HE
Arm Type
Active Comparator
Arm Description
Participants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months.
Intervention Type
Other
Intervention Name(s)
I2
Other Intervention Name(s)
Implementation Intentions
Intervention Description
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.).
Intervention Type
Other
Intervention Name(s)
Health Education
Intervention Description
Standard of care approach that will provide basic information on CRC screening.
Primary Outcome Measure Information:
Title
CRC screening completion rate
Description
Rate of participants who receive CRC screening during study participation
Time Frame
12-14 Months
Secondary Outcome Measure Information:
Title
Cost analysis of each intervention pathway
Description
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.
Time Frame
14 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Watson, MBA
Phone
(913) 945-6675
Email
awatson@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Greiner, MD, MPH
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph LeMaster, MD
First Name & Middle Initial & Last Name & Degree
Christina Hester, PhD

12. IPD Sharing Statement

Learn more about this trial

Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations

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