Colorectal Cancer Awareness, Research, Education and Screening (CARES)
NCT01804179 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 514
Last updated 2022-09-10
Summary
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.
Conditions
Interventions
- OTHER
-
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.
- OTHER
-
Standard Intervention (SI) Educational Materials
"Screen for Life" brochure
- OTHER
-
CARES Intervention Educational Materials
Newly developed digital video disc (DVD) and booklet
- OTHER
-
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.
- OTHER
-
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.
Sponsors & Collaborators
-
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Clement Gwede, PhD, MPH, RN · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-02-11
- Primary Completion
- 2015-01-31
- Completion
- 2022-09-09
Countries
- United States
Study Locations
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