A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care

NCT ID: NCT03407417

Last Updated: 2025-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2024-01-31

Brief Summary

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The purpose of this proposal is to test the efficacy of a patient-centered, tailored message intervention delivered via virtual technology for increasing colorectal cancer (CRC) screening within guidelines among racial/ethnic minority and rural patients. This protocol focuses on the clinical portion of grant NCI 1RCA207689-01A1

Detailed Description

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Patients will be recruited via a secure, clinical data warehouse to complete a patient-randomized test of the efficacy of the intervention for promoting initial and repeat FIT testing. Patients identified as eligible will be contacted through MyChart to test a web-based, culturally-sensitive virtual human intervention for CRC screening. The web-application will provide information to encourage CRC screening. Therefore, this study is a minimal risk study.

Conditions

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Colo-rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants
Study Team will recruit an ethnically diverse sample of eligible patients to complete the intervention.

Study Groups

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Virtual Human (VH)

Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements.

Group Type EXPERIMENTAL

virtual technology

Intervention Type OTHER

The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.

Text-Base (TB)

Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements.

Group Type EXPERIMENTAL

virtual technology

Intervention Type OTHER

The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.

Interventions

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virtual technology

The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.

Intervention Type OTHER

Other Intervention Names

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Virtual human application (ALEX)

Eligibility Criteria

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Inclusion Criteria

* able to read English or Spanish at least at eighth-grade level
* have an email account or the ability to receive texts
* willingness to be re-contacted
* consent to MRR related to CRC screening
* not remember completing any CRC screening within recommended guidelines (i.e., \<10 years for colonoscopy, \<1 year for stool test).
* complete a FIT test:
* a) with a negative result only
* b) complete a FIT test with a positive result AND undergo a completion screening colonoscopy,
* Or c) complete a colonoscopy only.

Exclusion Criteria

* unable to read English at least at eighth-grade level
* doesn't have an email account or the ability to receive texts
* unwilling to be re-contacted
* Unable to consent to MRR related to CRC screening
* have not had \<10 years for colonoscopy, or 1 year for stool test
Minimum Eligible Age

45 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Lok

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

University of Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01CA207689-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR17004

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201702765 -N

Identifier Type: -

Identifier Source: org_study_id

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