University of Florida
Gainesville, Florida, 32611, United States
NCT Number: NCT03867409
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.
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Notify Me50 year–73 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: immediately after the intervention, up to 1 hour
Measure: Intention to talk to doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: The virtual appointment made me want to discuss colon cancer screening options with my doctor.
Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to talk to a healthcare professional about colorectal cancer screening. Mean scores near 5 indicate a high intention to talk to a healthcare professional about colorectal cancer screening.
No subscales
Time frame: immediately after the intervention, up to 1 hour
Measure: Intention to Screen for Colorectal Cancer Item: I want to get screened for colorectal cancer. Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to get screened for colorectal cancer. Mean scores near 5 indicate a higher intention to get screened for colorectal cancer.
Construct: Behavioral intention to screen No subscales
Time frame: immediately after the intervention, up to 1 hour
Measure: Intention to Talk about Screening with FIT Item: I will talk to my healthcare provider about colon cancer screening with FIT.
Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores closer to 1 indicate a lower intention to screen with FIT. Mean scores closer to 5 indicate a high intention to screen with FIT.
Construct: Behavioral intention to screen with FIT No subscales
Time frame: immediately after the intervention, up to 1 hour
Measure: Intention to Recommend Intervention (ALEX) Item: Imagine you received a link to ALEX from your healthcare provider. Would you like to share it by sending the link to someone? Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to recommend ALEX. Mean scores near 5 indicate a high intention to recommend ALEX.
Construct: Behavioral intention to recommend ALEX No subscales
Time frame: immediately after the intervention, up to 1 hour
Measure:
Construct: Source Credibility
Scale description: An 18-item unidimensional 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate that information provided by ALEX was perceived as not credible. Mean scores near 5 indicate the information provided by ALEX was perceived as highly credible. No subscales. The scale includes the following items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Argument Strength; Description: Argument Strength is a 9-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measuring participants' perceptions of the strength of the argument about colon cancer screening. Mean scores near 1 indicate that ALEX's argument about colon cancer screening was perceived as not strong. Mean scores near 5 indicate that ALEX's argument about colon cancer screening was perceived as very strong. No subscales.
Time frame: immediately after the intervention, up to 1 hour
Construct: Internal Homophily
Scale: an 8-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measuring participants' perceptions of their similarity to ALEX's characteristics. Mean scores near 1 indicate participants perceive strong dissimilarity to ALEX's characteristics. Mean scores near 5 indicate participants perceive strong similarity to ALEX's characteristics. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Usability of App; Description: Usability is a 4-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree). This scale measures participants' experience using the ALEX app. Mean scores near 1 indicate a negative experience using the ALEX app. Mean scores near 5 indicate a positive experience using the ALEX app. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Perceived Severity; Description: A 4-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measuring participants' perceptions regarding the likelihood of developing colon cancer at some point in their lives. Mean scores near 1 indicate low severity, while mean scores near 5 indicate high severity. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Perceived Susceptibility Description: Perceived Susceptibility is a 4-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) assessing participants' perceptions regarding being susceptible to developing colon cancer at some point in their lives. Mean scores near 1 indicate low susceptibility, while mean scores near 5 indicate high susceptibility. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Response Efficacy Description: A 4-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measured participants' perceptions of the effectiveness of FIT screening in detecting and preventing colon cancer. Mean scores near 1 indicate low perceived efficacy, while mean scores near 5 indicate high perceived efficacy. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Self-Efficacy Description: A 12-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measuring participants' confidence in completing FIT screening or a colonoscopy. Mean scores near 1 indicate low self-efficacy, while scores near 5 indicate high self-efficacy. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Perceived Barriers Description: A 6-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) assessed participants' perceived obstacles to undergoing FIT screening. Mean scores closer to 1 indicate fewer perceived barriers. Mean scores closer to 5 indicate more perceived barriers. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Perceived Benefits Description: A 4-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measured participants' perceptions of the benefits of FIT screening. Mean scores near 1 indicate low perceived benefits. Mean scores near 5 indicate high perceived benefits. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Comparative Risk Feedback Description: A single-item unidimensional measure assessing participants' perceived risk of developing colon cancer compared to others on a 7-point Likert Scale. Mean scores near 1 indicate low perceived comparative risk. Mean scores near 7 indicate a high perceived risk of developing colon cancer compared to others. Item:
Time frame: immediately after the intervention, up to 1 hour
Construct: Cancer Information Overload Description: A 4-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measuring participants' perceptions regarding the amount and clarity of cancer-related information. Mean scores near 1 indicate lower overload. Mean scores near 5 indicate higher overload. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Perceived Message Relevance Description: A 6-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measuring participants' perceptions of how relevant and personalized the health message felt to them. Mean scores near 1 indicate low relevance. Mean scores near 5 indicate high relevance. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Trust in Physician Description: An 11-item 5-point Likert scale (1=strongly disagree/5=strongly agree) measuring physician trust. Mean scores near 1 indicate low trust, while scores near 5 indicate high trust. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Patient-Provider Communication Description: A 5-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measuring participants' perceptions of how well their doctor communicates with them. Mean scores near 1 indicate poor communication. Mean scores near 5 indicate good communication. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Patient General Health Description: A 3-item unidimensional measure assessing participants' overall health and pain levels on 5-point Likert Scales. Mean scores near 1 indicate low general health. Mean scores near 5 indicate high general health. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Health Literacy (eHeals) Description: An 8-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) measuring participants' confidence in using the internet for health-related information. Mean scores near 1 indicate low health literacy. Mean scores near 5 indicate high health literacy. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Interpersonal Distance Description: A 4-item unidimensional 5-point Likert scale (1=strongly disagree/5=strongly agree) that measures participants' perceptions of the virtual human's presence. Mean scores near 1 indicate low perceived presence. Mean scores near 5 indicate high perceived presence. No subscales. Items:
Time frame: immediately after the intervention, up to 1 hour
Construct: Attitudes towards Fecal Immunochemical Test (FIT) - Sad
Description: We measured participant's emotional attitudes of sadness towards FIT using single-items on a 5-point Likert scale (1=not at all, 5=very much). Mean scores near 1 indicate little to no feelings of sadness regarding FIT screening. Mean scores near 5 indicate strong feelings of sadness regarding FIT screening. Item:
Time frame: immediately after the intervention, up to 1 hour
Construct: Attitudes towards Fecal Immunochemical Test (FIT) - Worried
Description: We measured participant's emotional attitudes of worry towards FIT using single-items on a 5-point Likert scale (1=not at all, 5=very much). Mean scores near 1 indicate little to no feelings of worry regarding FIT screening. Mean scores near 5 indicate strong feelings of worry regarding FIT screening. Item:
Time frame: immediately after the intervention, up to 1 hour
Construct: Attitudes towards Fecal Immunochemical Test (FIT) - Relieved Description: We measured participant's emotional attitudes of relief towards FIT using single-items on a 5-point Likert scale (1=not at all, 5=very much). Mean scores near 1 indicate little to no feelings of relief regarding FIT screening. Mean scores near 5 indicate strong feelings of relief regarding FIT screening. Item:
Time frame: immediately after the intervention, up to 1 hour
Construct: Attitudes towards Fecal Immunochemical Test (FIT) - Tense
Description: We measured participant's emotional attitudes of tensity towards FIT using single-items on a 5-point Likert scale (1=not at all, 5=very much). Mean scores near 1 indicate little to no feelings of tenseness regarding FIT screening. Mean scores near 5 indicate strong feelings of tenseness regarding FIT screening. Item:
Time frame: immediately after the intervention, up to 1 hour
Construct: Attitudes towards Fecal Immunochemical Test (FIT) - Anxious
Description: We measured participant's emotional attitudes of anxiety towards FIT using single-items on a 5-point Likert scale (1=not at all, 5=very much). Mean scores near 1 indicate little to no feelings of anxiousness regarding FIT screening. Mean scores near 5 indicate strong feelings of anxiousness regarding FIT screening. Item:
Time frame: immediately after the intervention, up to 1 hour
Construct: Attitudes towards Fecal Immunochemical Test (FIT) - Calm
Description: We measured participant's emotional attitudes of calmness towards FIT using single-items on a 5-point Likert scale (1=not at all, 5=very much). Mean scores near 1 indicate little to no feelings of calmness regarding FIT screening. Mean scores near 5 indicate strong feelings of calmness regarding FIT screening. Item:
Time frame: immediately after the intervention, up to 1 hour
Construct: Attitudes towards Fecal Immunochemical Test (FIT) - Afraid
Description: We measured participant's emotional attitudes of fear towards FIT using single-items on a 5-point Likert scale (1=not at all, 5=very much). Mean scores near 1 indicate little to no feelings of fear regarding FIT screening. Mean scores near 5 indicate strong feelings of fear regarding FIT screening. Item:
University of Florida
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