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Completed

NCT Number: NCT03906110

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Behavioral

Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.

Personalized One on One Education

Behavioral
  • 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.

Fecal Immunochemical Test (FIT)

Diagnostic Test

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

Primary outcomes

  1. Fecal Immunochemical Test (FIT) use -Time Point 1

    Time frame: Time Point 1 (at 3 months)

    Participants use of FIT kits will be measured based on FIT sample return rate.

  2. Fecal Immunochemical Test (FIT) Use- Time Point 2

    Time frame: Time Point 2 (up to 18 months)

    Participants use of FIT kits will be measured based on FIT sample return rate.

  3. Fecal Immunochemical Test (FIT) Use- Time Point 3

    Time frame: Time Point 3 (End of study, up to 30 months)

    Participants long term FIT adherence will be measured based on FIT sample return rate.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Florida Department of Health

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2019
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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