Colorectal Cancer Awareness, Research, Education and Screening (CARES)

Study Overview
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Brief Summary
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There are two parts to this study: (1) an information gathering phase leading to the development of new educational materials; and (2) a study to test the newly developed material. The information gathering phase has been completed. The purpose of this part of the research study is to test the usefulness and acceptability of new educational materials investigators have developed. Investigators will compare the new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening.

Detailed Description
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Federally qualified health centers (FQHCs) and other community health clinics (CHCs) provide comprehensive primary health care for underserved patients. Recently, high-sensitivity and high-specificity fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) have emerged as a preferred initial screening modality within clinics due to convenience, ease of use, and low cost compared with colonoscopy. FOBT/FIT may help to reduce colorectal cancer screening (CRC) screening disparities and overcome several previously mentioned factors that often account for suboptimal CRC screening rates.

Official Title
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Colorectal Cancer Awareness, Research, Education and Screening (CARES)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
* Other: Standard Intervention (SI) Educational Materials
* Other: CARES Intervention Educational Materials
* Other: Baseline Visit Survey
* Other: Follow-up Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Racially-ethnically diverse adult men and women Average risk individuals who have no personal diagnosis, or presumptive symptoms of colorectal cancer (CRC), or are not at high risk Self-report as not current on screening Provide at least two forms of contact information and contact information of a relative (not living with respondent) to facilitate follow-up contacts Are able to speak, read and write English because the instruments and CARES intervention are available only in English at this time. We recognize that interventions are needed for non-English speaking populations, therefore, once we find promise in the English language CARES intervention materials, we will move forward with conducting other studies that involve translation of measures and cultural adaptation of the CARES intervention materials into Spanish or Haitian Creole. Exclusion Criteria: Individuals who have participated in a CRCS research study in the past 1 year will not be eligible for this study. Recent screening criteria relates to not having had I-FOBT within the previous year, flex sig within the previous 5 years, a double-contrast barium enema (DCBE) x-ray with the previous 5 years, or a colonoscopy within the previous 10 years. Within the recruitment and intervention frame, high risk individuals (due to strong family history, ulcerative colitis, polyposis syndromes) are excluded because they may be eligible for CRC screening before age 50, and the preferred screening option is certainly colonoscopy which is beyond the primary focus of the current 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Intervention (SI)<br>At Baseline Visit, Participants in the standard intervention (SI) condition will get: I-FOBT kit and Screen for Life brochure, a mailed reminder card at two weeks post-intervention to remind them about FOBT testing and follow up assessments at 12 months. | Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit<br>* Participants will receive an Immunochemical Fecal Occult Blood Test (I-FOBT) Kit (a home stool blood test) used as a first-step screening tool for colorectal cancer to take home. The research staff will provide instructions on how to use the kit.<br>* Other names: fecal immunochemical test (FIT);Other: Standard Intervention (SI) Educational Materials<br>* Screen for Life brochure<br>Other: Baseline Visit Survey<br>* In both conditions, patients will participate in a Baseline Survey. Three brief items will be used to assess patient-provider discussion and recommendation: (1) Was colorectal cancer or colorectal cancer screening one of the things you discussed with the doctor or health care provider? (Yes/No). (2) If Yes, who brought the topic of colorectal cancer first? (patient/health care provider). (3) Did your doctor or health care provider recommend colorectal cancer screening? (Yes/No). These questions are necessary to evaluate the impact of interventions on patient-provider discussion of CRCS and provider recommendation of CRCS.<br>Other: Follow-up Questionnaire<br>* 12 months after participants began to participate in the study, they will be contacted via telephone to complete a final set of questionnaires. Participants will be asked questions similar to those answered in baseline. This time they will ask about the participant's thoughts on the educational materials as well.<br>|
| Experimental: CARES Intervention<br>Colorectal Cancer Awareness, Research, Education and Screening (CARES). At Baseline Visit, Participants in the CARES intervention will receive: I-FOBT kit, a newly developed DVD and booklet, and a mailed reminder card at two weeks post-intervention to remind them about FOBT testing, and follow-up assessments at 12 months. | Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit<br>* Participants will receive an Immunochemical Fecal Occult Blood Test (I-FOBT) Kit (a home stool blood test) used as a first-step screening tool for colorectal cancer to take home. The research staff will provide instructions on how to use the kit.<br>* Other names: fecal immunochemical test (FIT);Other: CARES Intervention Educational Materials<br>* Newly developed digital video disc (DVD) and booklet<br>Other: Baseline Visit Survey<br>* In both conditions, patients will participate in a Baseline Survey. Three brief items will be used to assess patient-provider discussion and recommendation: (1) Was colorectal cancer or colorectal cancer screening one of the things you discussed with the doctor or health care provider? (Yes/No). (2) If Yes, who brought the topic of colorectal cancer first? (patient/health care provider). (3) Did your doctor or health care provider recommend colorectal cancer screening? (Yes/No). These questions are necessary to evaluate the impact of interventions on patient-provider discussion of CRCS and provider recommendation of CRCS.<br>Other: Follow-up Questionnaire<br>* 12 months after participants began to participate in the study, they will be contacted via telephone to complete a final set of questionnaires. Participants will be asked questions similar to those answered in baseline. This time they will ask about the participant's thoughts on the educational materials as well.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Test Kit Completion | Investigators will measure uptake of I-FOBT/FIT as any completed kit within 180 days of delivery of the intervention. That is, the proportion of participants who return a sampled kit by the 6 month assessment (investigators expect most kits to be returned much sooner) for calculation of the primary screening endpoint. I-FOBT/FIT use will be compared (CARES vs. SI). | 6 months post final enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Colorectal Cancer Screening (CRCS) With Any Test | Overall CRCS with any test will be compared (CARES vs. SI). It is expected that pairing I-FOBT/FIT kits with the CARES toolkit will result in greater CRCS uptake compared to SI plus I-FOBT/FIT. | 12 months post final enrollment | 
| Time to Kit Return | Maximum number of months required for kit return per study arm. | Up to 12 months post final enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon, rectum, cancer, screening, questionnaire, testing, educational materials