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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Colorectal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01804179

MCC-16447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 514 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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514 participants in 2 patient groups

Standard Intervention (SI)

Active Comparator group

Description:

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.

Treatment:

Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit

Other: Follow-up Questionnaire

Other: Baseline Visit Survey

Other: Standard Intervention (SI) Educational Materials

CARES Intervention

Experimental group

Description:

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.

Treatment:

Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit

Other: Follow-up Questionnaire

Other: Baseline Visit Survey

Other: CARES Intervention Educational Materials