Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations

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

Detailed Description
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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.

Official Title
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Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: I2
* Other: Health Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Screening, Colon Cancer, Colon Cancer Screening