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

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01804179
Collaborator
(none)
514
1
2
148.6
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Immunochemical Fecal Occult Blood Test (I-FOBT) Kit
  • Other: Standard Intervention (SI) Educational Materials
  • Other: CARES Intervention Educational Materials
  • Other: Baseline Visit Survey
  • Other: Follow-up Questionnaire
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
514 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Colorectal Cancer Awareness, Research, Education and Screening (CARES)
Actual Study Start Date :
Feb 11, 2011
Actual Primary Completion Date :
Jan 31, 2015
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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 Names:
  • Home Stool Blood Test
  • fecal immunochemical test (FIT)
  • Other: Standard Intervention (SI) Educational Materials
    "Screen for Life" brochure

    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.

    Experimental: 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.

    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 Names:
  • Home Stool Blood Test
  • fecal immunochemical test (FIT)
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Test Kit Completion [6 months post final enrollment]

      Investigators will measure uptake of I-FOBT/FIT as any completed kit within 180 days of delivery of the intervention. That is, the proportion of participants who return a sampled kit by the 6 month assessment (investigators expect most kits to be returned much sooner) for calculation of the primary screening endpoint. I-FOBT/FIT use will be compared (CARES vs. SI).

    Secondary Outcome Measures

    1. Overall Colorectal Cancer Screening (CRCS) With Any Test [12 months post final enrollment]

      Overall CRCS with any test will be compared (CARES vs. SI). It is expected that pairing I-FOBT/FIT kits with the CARES toolkit will result in greater CRCS uptake compared to SI plus I-FOBT/FIT.

    2. Time to Kit Return [Up to 12 months post final enrollment]

      Maximum number of months required for kit return per study arm.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612

    Sponsors and Collaborators

    • H. Lee Moffitt Cancer Center and Research Institute

    Investigators

    • Principal Investigator: Clement Gwede, PhD, MPH, RN, H. Lee Moffitt Cancer Center and Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT01804179
    Other Study ID Numbers:
    • MCC-16447
    First Posted:
    Mar 5, 2013
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022