Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES)
1 other identifier
observational
327
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2018
CompletedFirst Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2022
CompletedApril 20, 2023
April 1, 2023
4.1 years
April 4, 2019
April 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
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)
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)
Study Arms (2)
C-Cares
Participants will be given Community Colorectal Cancer Awareness, Research, Education and Screening (C-CARES) Materials and FIT kits.
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.
Interventions
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.
Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.
* 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.
The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample.
Eligibility Criteria
Established patients of community health clinics aged 50-75 with average risk of colorectal cancer.
You may qualify if:
- 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
You may not qualify if:
- Symptoms of colorectal cancer
- Family history of colorectal cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Related 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.
PMID: 35305995BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clement K Gwede, PhD, MPH, RN
H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 8, 2019
Study Start
April 3, 2018
Primary Completion
May 26, 2022
Study Completion
May 26, 2022
Last Updated
April 20, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share