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

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ClinicalTrials.gov Identifier: NCT03100461
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Kansas Medical Center

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: I2 Other: Health Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : March 31, 2021

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: 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 Name: Implementation Intentions

Other: Health Education
Standard of care approach that will provide basic information on CRC screening.

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 Name: 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: 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 Name: Implementation Intentions

Other: Health Education
Standard of care approach that will provide basic information on CRC screening.




Primary Outcome Measures :
  1. CRC screening completion rate [ Time Frame: 12-14 Months ]
    Rate of participants who receive CRC screening during study participation


Secondary Outcome Measures :
  1. Cost analysis of each intervention pathway [ Time Frame: 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.



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100461


Contacts
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Contact: Angela Watson, MBA (913) 945-6675 awatson@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sub-Investigator: Joseph LeMaster, MD         
Sub-Investigator: Christina Hester, PhD         
Sponsors and Collaborators
University of Kansas Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Allen Greiner, MD, MPH University of Kansas Medical Center
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03100461    
Other Study ID Numbers: STUDY00002929
1R01CA188898-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
Cancer Screening
Colon Cancer
Colon Cancer Screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases