Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants

Study Overview
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Brief Summary
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RATIONALE: Developing a personalized screening plan may be more effective than usual care in increasing the number of healthy participants who regularly undergo screening for colorectal cancer. PURPOSE: This randomized phase III trial is studying personalized screening plans to see how well they work compared with usual care in increasing colorectal cancer screening in healthy participants.

Detailed Description
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OBJECTIVES: To compare the impact of tailored intervention vs standard intervention vs usual care on patient utilization of colorectal cancer (CRC) screening. To compare the impact of these interventions on CRC screening preference. To compare the impact of these interventions on patient perceptions about CRC screening. OUTLINE: This is a multicenter study. Participants are stratified by practice and study wave and blocking. Participants are randomized to 1 of 3 arms. Arm I (usual care): Participants receive usual care in accordance with their normal patterns of interaction with study practices. Arm II (standard intervention [SI]): A generic screening invitation letter, a colorectal cancer (CRC) screening informational booklet, stool blood testing (SBT) cards, and instructions for arranging a colonoscopy screening appointment are mailed to participants on day 15. On day 45, a reminder letter is mailed to participants who have not completed SBT or undergone a screening colonoscopy. Arm III (tailored navigation intervention [TNI]): A test-specific screening invitation letter, a CRC screening informational booklet, and additional test-specific materials (i.e., instructions for arranging a colonoscopy screening appointment or SBT cards) are mailed to participants on day 15. On day 30, a patient navigator contacts participants by telephone who have not completed SBT or undergone a screening colonoscopy. The patient navigator re-assesses screening test-specific decision stage; addresses CRC screening barriers; develops a personalized CRC screening plan to move the participant towards screening use (i.e., explains the steps in completing the SBT or scheduling a colonoscopy appointment); and facilitates screening plan implementation. On day 45, a reminder letter is mailed to participants who were contacted by the navigator. Participants in all arms complete a survey at baseline and then at 6 months. Medical records for each participant are reviewed at 6 months.

Official Title
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Tailored Navigation in CRC Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: medical chart review
* Other: survey administration
* Procedure: fecal occult blood test
* Procedure: screening colonoscopy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets the following criteria: No personal history of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease No family history of colorectal cancer (CRC) diagnosed before the age of 60 Visited one of the six community-based primary care practices that are part of the Christiana Care Health System (CCHS) in Delaware within the past 2 years Not up-to-date with CRC screening, according to the United States Preventive Services Task Force guidelines PATIENT CHARACTERISTICS: Must have a complete address and telephone number Able to communicate in English No psychosis or severe dementia PRIOR CONCURRENT THERAPY: No prior participation in the developmental study CA10241

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 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: Health Services Research
Allocation: Randomized
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: medical chart review|nan|
|Other: survey administration|nan|
|Procedure: fecal occult blood test|nan|
|Procedure: screening colonoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening utilization over the 6-month observation period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening preference |  |  | 
| Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening |  |  | 
| Number and length of contacts with each participant and the type of communication during those contacts |  |  | 
| Identification of predictors of CRC screening use and screening preference |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer