Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES)

Colorectal Cancer Clinical Trial

Official title:

Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) : A Multilevel Intervention to Increase Colorectal Cancer Screening Adherence In Community Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906110
• Other study ID #: MCC-19106
• Status: Completed
• Start date: April 3, 2018
• Est. completion date: May 26, 2022

Study information

• Verified date: April 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to test if including personalization in education materials about colorectal cancer screening is more effective at helping encourage people to complete colorectal cancer screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: May 26, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Able to understand, read and speak English or Spanish
• Are not up-to-date with colorectal cancer screening
• No symptoms of colorectal cancer
• Not at increased risk for colorectal cancer due to family history or personal high-risk GI syndromes

Exclusion Criteria:

• Symptoms of colorectal cancer
• Family history of colorectal cancer

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials
Educational materials (photonovella +DVD) + Fecal Immunochemical Test (FIT) kit. Offers colorectal cancer screening information using a novella format. Materials describe colorectal cancer and screening tests that are available, and procedures for completing FIT kit.
• Contact Message
Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.
• Personalized One on One Education
Trained study coordinators will meet with participant for a brief 15 minute educational session delivered in clinic that summarizes information from the materials and demonstrates FIT collection. Email or text reminders with brief messages in clear language will be sent that aim to remind and prompt patients to complete FIT. For participants that are not responsive to above, trained study staff will address specific FIT specific hinderances by telephone or in clinic. Participants will receive a one page summary of key points of salience of repeat screening "GET FIT AGAIN". Another FIT kit is provided.

Diagnostic Test:
• Fecal Immunochemical Test (FIT)
The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Florida Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Christy SM, Sutton SK, Abdulla R, Boxtha C, Gonzalez P, Cousin L, Ewing A, Montoya S, Lopez D, Beehler T, Sanchez J, Carvajal R, Meade CD, Gwede CK. A multilevel, low literacy dual language intervention to promote colorectal cancer screening in community clinics in Florida: A randomized controlled trial. Prev Med. 2022 May;158:107021. doi: 10.1016/j.ypmed.2022.107021. Epub 2022 Mar 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal Immunochemical Test (FIT) use -Time Point 1	Participants use of FIT kits will be measured based on FIT sample return rate.	Time Point 1 (at 3 months)
Primary	Fecal Immunochemical Test (FIT) Use- Time Point 2	Participants use of FIT kits will be measured based on FIT sample return rate.	Time Point 2 (up to 18 months)
Primary	Fecal Immunochemical Test (FIT) Use- Time Point 3	Participants long term FIT adherence will be measured based on FIT sample return rate.	Time Point 3 (End of study, up to 30 months)

External Links

•   Moffitt Cancer Center Clinical Trials Website