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

NCT01804179 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2022-09-10

No results posted yet for this study

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.

Conditions

Interventions

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

Standard Intervention (SI) Educational Materials

"Screen for Life" brochure

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-11
Primary Completion
2015-01-31
Completion
2022-09-09

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804179 on ClinicalTrials.gov