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

50 Years
75 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Frequency of Immunochemical Fecal Occult Blood Test (I-FOBT) Kit Use

Outcome Description:

We will measure uptake of I-FOBT as any completed I-FOBT kit by the 12 month post-intervention assessment. That is, the proportion of participants who return a sampled I-FOBT kit by the 12-month assessment (most I-FOBT kits will be returned much sooner) will be estimated for calculation of the primary screening endpoint. I-FOBT use will be compared (CARES vs. SI). It is expected that pairing I-FOBT kits with the CARES toolkit will result in greater CRCS uptake compared to SI plus I-FOBT.

Outcome Time Frame:

12 Months Post Intervention

Safety Issue:


Principal Investigator

Clement Gwede, Ph.D., MPH, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

February 2011

Completion Date:

April 2015

Related Keywords:

  • Colorectal Cancer
  • colon
  • rectum
  • cancer
  • screening
  • questionnaire
  • testing
  • educational materials
  • Colorectal Neoplasms



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612