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

NCT01804179 | Completed

• 1 other identifier: MCC-16447
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months post final enrollment

Secondary Outcomes (2)

• Overall Colorectal Cancer Screening (CRCS) With Any Test

  12 months post final enrollment

• Time to Kit Return

  Up to 12 months post final enrollment

Study Arms (2)

Standard Intervention (SI)

ACTIVE COMPARATOR

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; Other: Standard Intervention (SI) Educational Materials; Other: Baseline Visit Survey; Other: Follow-up Questionnaire

CARES Intervention

EXPERIMENTAL

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; Other: CARES Intervention Educational Materials; Other: Baseline Visit Survey; Other: Follow-up Questionnaire

Interventions

Immunochemical Fecal Occult Blood Test (I-FOBT) Kit OTHER

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.

Also known as: Home Stool Blood Test, fecal immunochemical test (FIT)

CARES Intervention; Standard Intervention (SI)

Standard Intervention (SI) Educational Materials OTHER

"Screen for Life" brochure

Standard Intervention (SI)

CARES Intervention Educational Materials OTHER

Newly developed digital video disc (DVD) and booklet

CARES Intervention

Baseline Visit Survey OTHER

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.

CARES Intervention; Standard Intervention (SI)

Follow-up Questionnaire OTHER

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.

CARES Intervention; Standard Intervention (SI)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• A Randomized Controlled Trial of a Multicomponent, Targeted, Low-Literacy Educational Intervention Compared With a Nontargeted Intervention to Boost Colorectal Cancer Screening With Fecal Immunochemical Testing in Community Clinics

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Receptor Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Clement Gwede, PhD, MPH, RN

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 5, 2013
• Study Start: February 11, 2011
• Primary Completion: January 31, 2015
• Study Completion: September 9, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-08

Locations

US (1)