The United States Healthy Living Study

NCT ID: NCT03867409

Last Updated: 2025-05-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2019-03-14

Brief Summary

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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.

Detailed Description

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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.

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
The study design will be a message design experiment for delivering a CRC intervention. Participants will receive a racially concordant virtual human message or a racially concordant text-based message based on their self-reported demographics (white or black).

Study Groups

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Virtual Human (VH) Demographically Concordant - Black

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

Group Type EXPERIMENTAL

message delivered via virtual technology

Intervention Type BEHAVIORAL

The intervention is 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.

Virtual Human (VH) Demographically Concordant - White

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

Group Type EXPERIMENTAL

message delivered via virtual technology

Intervention Type BEHAVIORAL

The intervention is 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.

Text-Based Demographically Concordant - Black

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

Group Type ACTIVE_COMPARATOR

message delivered via virtual technology

Intervention Type BEHAVIORAL

The intervention is 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.

Text-Based Demographically Concordant - White

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

Group Type ACTIVE_COMPARATOR

message delivered via virtual technology

Intervention Type BEHAVIORAL

The intervention is 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.

Interventions

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message delivered via virtual technology

The intervention is 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 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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Janice Krieger, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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5R01CA207689-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR19177

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201801473 -N

Identifier Type: -

Identifier Source: org_study_id

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