Clinical trial NCT01804179: Colorectal Cancer Awareness, Research, Education and Screening (CARES)
Official title: Colorectal Cancer Awareness, Research, Education and Screening (CARES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon
rectum
cancer
screening
questionnaire
testing
educational materials
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 514
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Test Kit Completion
timeFrame: 6 months post final enrollment
Secondary outcomes:
measure: Overall Colorectal Cancer Screening (CRCS) With Any Test
timeFrame: 12 months post final enrollment
measure: Time to Kit Return
timeFrame: Up to 12 months post final enrollment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Clement Gwede, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: