The United States Healthy Living Study

University of Florida

Status: Completed

Conditions: Colo-rectal Cancer

Treatments: Behavioral: message delivered via virtual technology

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03867409

5R01CA207689-02 (U.S. NIH Grant/Contract)

IRB201801473 -N

OCR19177 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to pilot test the efficacy of a patient-centered, tailored message intervention delivered via virtual human technology for increasing colorectal cancer (CRC) screening within guidelines. Although participation is not limited to these groups, the study team is particularly interested in the feasibility of the intervention for reaching racial/ethnic minority and rural patients.

Full description

The primary goal of the study is to reduce colorectal cancer (CRC) morbidity and mortality by increasing CRC screening rates among the at-risk patient community and to reduce racial and geographic (rural vs. urban) disparities in CRC screening and mortality rates. To accomplish this long-term goal, this study aims to develop and test precision messaging tailored to target audiences through development and evaluation of culturally sensitive, interactive messages about CRC screening delivered using VHT. The study will investigate whether interactive, tailored messages contribute to an overall enhancement of knowledge of CRC and screening options by eliciting positive attitudes and behaviors toward FIT screening.

To date, there is no other study that has looked to partner specific message strategies and colorectal cancer screening with an emphasis on racial concordance and modality. As such, the researchers hope to shed new light on how, as health communicators, to more successfully engage target audiences to change attitudes and/or behaviors towards getting screened for colorectal cancer.

Enrollment: 2,105 patients

Sex: All

Ages: 50 to 73 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• reside within the United States but outside of Florida
• speak English
• are of either black or white racial background.
• are out-of-guidelines for colorectal cancer screening (>10 years for colonoscopy, >3 years for Cologuard, > 1 year for fecal immunochemical test)

Exclusion criteria

• does not meet the above criteria

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,105 participants in 4 patient groups

Virtual Human (VH) Demographically Concordant - Black

Experimental group

Description:

Participants received colorectal cancer screening information using a virtual human that matched their self-reported demographics.

Treatment:

Behavioral: message delivered via virtual technology

Virtual Human (VH) Demographically Concordant - White

Experimental group

Description:

Participants received colorectal cancer screening information using a virtual human that matched their self-reported demographics.

Treatment:

Behavioral: message delivered via virtual technology

Text-Based Demographically Concordant - Black

Active Comparator group

Description:

Participants received colorectal cancer screening information using a text-based message that matched their self-reported demographics.

Treatment:

Behavioral: message delivered via virtual technology

Text-Based Demographically Concordant - White

Active Comparator group

Description:

Participants received colorectal cancer screening information using a text-based message that matched their self-reported demographics.

Treatment:

Behavioral: message delivered via virtual technology