Clinical trial NCT03867409: The United States Healthy Living Study
Official title: The United States Healthy Living Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colo-rectal Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-08
Enrollment: 2105
Sex: ALL
Minimum age (years): 50
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intention to Talk to Doctor About Colorectal Cancer Screening
timeFrame: immediately after the intervention, up to 1 hour
measure: Intention to Screen for Colorectal Cancer
timeFrame: immediately after the intervention, up to 1 hour
measure: Intention to Talk About Screening With FIT
timeFrame: immediately after the intervention, up to 1 hour
measure: Intention to Recommend Intervention (ALEX)
timeFrame: immediately after the intervention, up to 1 hour
measure: Source Credibility
timeFrame: immediately after the intervention, up to 1 hour
measure: Argument Strength
timeFrame: immediately after the intervention, up to 1 hour
measure: Homophily
timeFrame: immediately after the intervention, up to 1 hour
measure: Usability of App
timeFrame: immediately after the intervention, up to 1 hour
measure: Perceived Severity
timeFrame: immediately after the intervention, up to 1 hour
measure: Perceived Susceptibility
timeFrame: immediately after the intervention, up to 1 hour
measure: Response Efficacy
timeFrame: immediately after the intervention, up to 1 hour
measure: Self-Efficacy
timeFrame: immediately after the intervention, up to 1 hour
measure: Perceived Barriers
timeFrame: immediately after the intervention, up to 1 hour
measure: Perceived Benefits
timeFrame: immediately after the intervention, up to 1 hour
measure: Comparative Risk Feedback
timeFrame: immediately after the intervention, up to 1 hour
measure: Cancer Information Overload
timeFrame: immediately after the intervention, up to 1 hour
measure: Perceived Message Relevance
timeFrame: immediately after the intervention, up to 1 hour
measure: Trust in Physician
timeFrame: immediately after the intervention, up to 1 hour
measure: Patient-Provider Communication
timeFrame: immediately after the intervention, up to 1 hour
measure: Patient General Health
timeFrame: immediately after the intervention, up to 1 hour
measure: Health Literacy (eHeals)
timeFrame: immediately after the intervention, up to 1 hour
measure: Interpersonal Distance
timeFrame: immediately after the intervention, up to 1 hour
measure: Attitudes Towards Fecal Immunochemical Test (FIT) - Sad
timeFrame: immediately after the intervention, up to 1 hour
measure: Attitudes Towards Fecal Immunochemical Test (FIT) - Worried
timeFrame: immediately after the intervention, up to 1 hour
measure: Attitudes Towards Fecal Immunochemical Test (FIT) - Relieved
timeFrame: immediately after the intervention, up to 1 hour
measure: Attitudes Towards Fecal Immunochemical Test (FIT) - Tense
timeFrame: immediately after the intervention, up to 1 hour
measure: Attitudes Towards Fecal Immunochemical Test (FIT) - Anxious
timeFrame: immediately after the intervention, up to 1 hour
measure: Attitudes Towards Fecal Immunochemical Test (FIT) - Calm
timeFrame: immediately after the intervention, up to 1 hour
measure: Attitudes Towards Fecal Immunochemical Test (FIT) - Afraid
timeFrame: immediately after the intervention, up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Janice Krieger, PhD
role: PRINCIPAL_INVESTIGATOR
References: