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

University of Kansas

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: I2; Other: Health Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03100461

1R01CA188898-01A1 (U.S. NIH Grant/Contract)

STUDY00002929

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 4 patient groups

HE + HE

Active Comparator group

Description:

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

Treatment:

Other: Health Education

HE + I2

Active Comparator group

Description:

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

Treatment:

Other: Health Education

Other: I2

I2 + I2

Experimental group

Description:

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

Treatment:

Other: I2

I2 + HE

Active Comparator group

Description:

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

Treatment:

Other: Health Education

Other: I2