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

NCT ID: NCT03906110

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

327 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-03

Study Completion Date

2022-05-26

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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C-Cares

Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) Materials and FIT kits.

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

Intervention Type 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

Intervention Type BEHAVIORAL

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

Fecal Immunochemical Test (FIT)

Intervention Type DIAGNOSTIC_TEST

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

C-Cares Plus

Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) materials, FIT kits, and personalized one-on-one education and coaching.

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

Intervention Type 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

Intervention Type 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

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type BEHAVIORAL

Contact Message

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Fecal Immunochemical Test (FIT)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida Department of Health

OTHER_GOV

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clement K Gwede, PhD, MPH, RN

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 35305995 (View on PubMed)

Other Identifiers

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MCC-19106

Identifier Type: -

Identifier Source: org_study_id

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