Colorectal Cancer Awareness, Research, Education and Screening (CARES)
NCT ID: NCT01804179
Last Updated: 2022-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
514 participants
INTERVENTIONAL
2011-02-11
2022-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Standard Intervention (SI)
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.
Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
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.
Standard Intervention (SI) Educational Materials
"Screen for Life" brochure
Baseline Visit Survey
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.
Follow-up Questionnaire
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.
CARES Intervention
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.
Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
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.
CARES Intervention Educational Materials
Newly developed digital video disc (DVD) and booklet
Baseline Visit Survey
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.
Follow-up Questionnaire
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.
Interventions
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Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
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.
Standard Intervention (SI) Educational Materials
"Screen for Life" brochure
CARES Intervention Educational Materials
Newly developed digital video disc (DVD) and booklet
Baseline Visit Survey
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.
Follow-up Questionnaire
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
75 Years
ALL
Yes
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Clement Gwede, PhD, MPH, RN
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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Related Links
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A Randomized Controlled Trial of a Multicomponent, Targeted, Low-Literacy Educational Intervention Compared With a Nontargeted Intervention to Boost Colorectal Cancer Screening With Fecal Immunochemical Testing in Community Clinics
Other Identifiers
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MCC-16447
Identifier Type: -
Identifier Source: org_study_id
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