Back to results

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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Immunochemical Fecal Occult Blood Test (I-FOBT) Kit

Standard Intervention (SI) Educational Materials

CARES Intervention Educational Materials

Baseline Visit Survey

Follow-up Questionnaire

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring colon, rectum, cancer, screening, questionnaire, testing, educational materials

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Intervention (SI)

CARES Intervention

Arm 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.

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.

Outcomes

Primary Outcome Measures

Rate of Test Kit Completion

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

Overall Colorectal Cancer Screening (CRCS) With Any Test

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.

Time to Kit Return

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

Full Information

NCT ID

NCT01804179

First Posted

March 1, 2013

Last Updated

September 9, 2022

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01804179

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

February 11, 2011 (Actual)

Primary Completion Date

January 31, 2015 (Actual)

Study Completion Date

September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

colon, rectum, cancer, screening, questionnaire, testing, educational materials

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

514 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Intervention (SI)

Arm Type

Active Comparator

Arm Description

Arm Title

CARES Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Immunochemical Fecal Occult Blood Test (I-FOBT) Kit

Other Intervention Name(s)

Home Stool Blood Test, fecal immunochemical test (FIT)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard Intervention (SI) Educational Materials

Intervention Description

"Screen for Life" brochure

Intervention Type

Other

Intervention Name(s)

CARES Intervention Educational Materials

Intervention Description

Newly developed digital video disc (DVD) and booklet

Intervention Type

Other

Intervention Name(s)

Baseline Visit Survey

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Follow-up Questionnaire

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of Test Kit Completion

Description

Time Frame

6 months post final enrollment

Secondary Outcome Measure Information:

Title

Overall Colorectal Cancer Screening (CRCS) With Any Test

Description

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.

Time Frame

12 months post final enrollment

Title

Time to Kit Return

Description

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

Time Frame

Up to 12 months post final enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clement Gwede, PhD, MPH, RN

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs