The United States Healthy Living Study

Colo-rectal Cancer Clinical Trial

Official title:

The United States Healthy Living Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867409
• Other study ID #: IRB201801473 -N
• Secondary ID: 5R01CA207689-02O
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: March 14, 2019

Study information

• Verified date: March 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2218
• Est. completion date: March 14, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Rectal Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived susceptibility	Perceived susceptibility (Birmingham et al., 2015) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; I am at risk for getting colon cancer in my lifetime.; It is possible that I will get colon cancer in my lifetime.; I am susceptible to getting colon cancer in my lifetime.; It is likely that I will get colon cancer in my lifetime.	immediately after the intervention
Primary	Perceived severity	Perceived severity (Boonyasiriwat et al., 2013; Hsien Cheah, 2006; Lipkus & Klein, 2006) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 5. I believe that colon cancer is harmful. 6. I believe that colon cancer is a significant disease. 7. I believe that colon cancer has serious negative consequences. 8. I believe that colon cancer is serious. 9. I believe that colon cancer is dangerous. 10. I believe that colon cancer is life-threatening.	immediately after the intervention
Primary	Perceived benefits	Perceived benefits (Christy et al., 2013; Purnell, Katz, Andersen, & Bennett, 2010; Rawl et al., 2001; Vernon, Myers, & Tilley, 1997) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 13. The FIT will decrease your chances of dying from colon cancer. 14. The FIT will help you not worry as much about colon cancer. 15. I believe that if I had a normal screening test result, I wouldn't have to worry about developing colon cancer.; 16. I believe that when colon cancer is found early, it can be cured.	immediately after the intervention
Primary	Perceived barriers	Perceived barriers (Champion & Skinner, 2003; Gwede et al., 2011; James, Campbell, & Hudson, 2002) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 17. My doctor would never recommend the FIT. 18. The FIT would be too expensive. 19. The FIT would be too embarrassing. 20. Preparation for the FIT is too hard. 21. The FIT takes too much time. 22. The FIT is difficult because it is too hard to understand all the instructions.	immediately after the intervention
Primary	Attitudes towards Fecal immunochemical test (FIT)	Attitudes towards FIT/colonoscopy (Rydell, Sherman, Boucher, & Macy, 2012) Please indicate your feelings about FIT. Numbers 1 and 5 indicate a very strong feeling. Numbers 2 and 4 indicate a weak feeling. Number 3 indicates you are undecided.; FIT is… 23. Awful—Nice 24. Unpleasant—Pleasant 25. Fun—Not Fun	immediately after the intervention
Primary	Attitudes towards colonoscopy	Attitudes towards FIT/colonoscopy (Rydell, Sherman, Boucher, & Macy, 2012) Please indicate your feelings about colonoscopy. Numbers 1 and 5 indicate a very strong feeling. Numbers 2 and 4 indicate a weak feeling. Number 3 indicates you are undecided.; Colonoscopy is… 26. Awful—Nice 27. Unpleasant—Pleasant 28. Fun—Not Fun	immediately after the intervention
Primary	Self-efficacy	Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; I am confident that I can use the FIT. Arranging my schedule to use the FIT is an easy thing to do. FIT screening would be easy for me to do. It would be easy for me to take a stool sample. It would be easy for me to mail my kit back. It would be easy for me to use all the tools in the kit. I know how to collect a stool sample. I am confident that I can get a colonoscopy. Arranging my schedule to get a colonoscopy is an easy thing to do. Finding time to get a colonoscopy would be difficult for me to do. Screening for colon cancer with a colonoscopy would be easy for me to do. It would be easy for me to get a colonoscopy.	immediately after the intervention
Primary	Response efficacy	Response efficacy (Boer & Seydel, 1996; Duncan et al., 2014; Hwang et al., 2012, 2013; Vernon et al., 1997) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 7. FIT screening leads to early detection if something is wrong. 8. FIT screening leads to the detection of small abnormalities. 9. FIT screening will help me find cancer early. (What has Nick gotten from something like this?) 10. FIT screening will decrease my chances of dying from colon cancer	immediately after the intervention
Primary	Comparative risk feedback	Comparative risk feedback (Dillard, Ferrer, Ubel, & Fagerlin, 2012; Weinstein et al., 2004) 11. Compared to the average person—your age, gender, and race—how would you rate your chances of developing colon cancer in your life? (Very much higher, much higher, higher, average, lower, much lower, very much lower)	immediately after the intervention
Primary	Cancer Information Overload	Cancer Information Overload (Jensen, Carcioppolo, et al., 2014) Below are some statements about the information you read and hear about cancer. For each statement, please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 12. There are so many different recommendations about preventing cancer, it's hard to know which ones to follow.; 13. There is not enough time to do all of the things recommended to prevent cancer.; 14. It has gotten to the point where I don't even care to hear new information about cancer.; 15. I feel overwhelmed by the amount of cancer information I am supposed to know.	immediately after the intervention
Primary	Cancer fatalism	Cancer fatalism (Powe, 1995; Shen, Condit, & Wright, 2009) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 11. I will die if I get colon cancer. 12. If I am diagnosed with colon cancer, I have little chance of surviving the disease.	immediately after the intervention
Primary	Perceived Message Relevance Scale	Perceived Message Relevance Scale (Jensen, King, et al., 2014; Jensen, King, Carcioppolo, & Davis, 2012) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 16. The message seemed to be written personally for me. 17. The message was very relevant to my situation. 18. The message was applicable to me. 19. The message was very customized to me. 20. This message was manipulative. 21. This message was misleading.	immediately after the intervention
Primary	Argument strength	Argument strength (Zhao, Strasser, Cappella, Lerman, & Fishbein, 2011) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree) about colon cancer screening.; 22. The visit is a reason for screening with FIT that is believable. 23. The visit is a reason for screening with FIT that is convincing. 24. The visit is gives me a reason for screening with FIT that is important to me.; 25. The visit helped me feel confident about how best to screen with FIT. 26. The visit would help my friends screen with FIT. 27. The visit put thoughts in my mind about wanting to screen with FIT. 28. The statement put thoughts in my mind about not wanting to avoid screening. 29. Overall, how much do you agree or disagree with the visit? 30. Is the reason the visit gave for screening with FIT a strong reason or weak reason?	immediately after the intervention
Primary	Source credibility	Source credibility (McCroskey & Teven, 1999) Please indicate your feelings about Alex. Numbers 1 and 5 indicate a very strong feeling. Numbers 2 and 4 indicate a weak feeling. Number 3 indicates you are undecided.; 37. Intelligent—Unintelligent 38. Trained—Untrained 39. Cares about me—Doesn't care about me 40. Honest—Dishonest 41. Has my interests at heart—Doesn't have my interests at heart 42. Trustworthy—Untrustworthy 43. Expert—Inexpert 44. Not self-centered—Self-centered 45. Concerned with me—Not concerned with me 46. Honorable—Dishonorable 47. Informed—Uninformed 48. Moral—Immoral 49. Competent—Incompetent 50. Ethical—Unethical 51. Sensitive—Insensitive 52. Bright—Stupid 53. Genuine—Phony 54. Understanding—Not understanding	immediately after the intervention
Primary	Trust in Physician Scale	Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; I doubt that my doctor really cares about me as a person. My doctor usually puts my needs first. I trust my doctor so much I always try to follow his/her advice. If my doctor tells me something is so, then it must be true. I sometimes distrust my doctor's opinion. I trust my doctor's judgments about my medical care. I feel my doctor does not do everything he/she should about my medical care. I trust my doctor to put my medical needs above all other considerations when treating my medical problems.; My doctor is well qualified to manage (diagnose and treat or make an appropriate referral) medical problems like mine.; I trust my doctor to tell me if a mistake was made about my treatment. I sometimes worry that my doctor may not keep the information we discuss totally private.	immediately after the intervention
Primary	Patient-provider communication scale	Patient-provider communication scale (Katz et al., 2004) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 66. I receive enough understandable information from my doctor/healthcare provider to make good decisions about my health.; 67. I feel rushed during visits. 68. My doctor/healthcare provider involves me in decisions about my health care treatment.; 69. I feel uncomfortable asking my doctor for tests or information if he/she doesn't mention it.; 70. My doctor/healthcare provider understands my health needs.	immediately after the intervention
Primary	Patient general health (SF-36)	Patient general health (SF-36) (Fan, Burman, McDonell, & Fihn, 2005; Jenkinson, Coulter, & Wright, 1993; RAND Corporation, n.d.) 71. In general, would you say your health is: Excellent; Very good; Good; Fair; Poor 72. How much bodily pain have you had during the past 4 weeks?; None; Very mild; Mild; Moderate; Severe; Very severe 73. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?; Not at all; A little bit; Moderately; Quite a bit; Extremely	immediately after the intervention
Primary	eHeals Health Literacy	eHeals Health Literacy (Norman & Skinner, 2006) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 74. I know how to find helpful health resources on the Internet. 75. I know how to use the Internet to answer my health questions. 76. I know what health resources are available on the Internet. 77. I know where to find helpful health resources on the Internet. 78. I know how to use the health information I find on the Internet to help me. 79. I have the skills I need to evaluate the health resources I find on the Internet.; 80. I can tell high quality from low quality health resources on the Internet. 81. I feel confident in using information from the Internet to make health decisions.	immediately after the intervention
Primary	Transportation	Transportation (Green & Brock, 2000) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 82. During the appointment, I could easily picture myself in the exam room. 83. While I was reading the narrative, activity going on in the room around me was not on my mind.; 84. I could picture myself in the scene of the events described in the narrative.; 85. I was mentally involved in the conversation while reading it. 86. After finishing the appointment, I found it easy to put it out of my mind. 87. I wanted to learn how the narrative ended. 88. The appointment affected me emotionally. 89. I found myself thinking of ways the narrative could have turned out differently.; 90. I found my mind wandering while reading the narrative. 91. The events in the narrative are relevant to my everyday life. 92. The events in the narrative have changed my life.	immediately after the intervention
Primary	Usability of App	In the last 12 months, how often have you used a secure website or application ("app") to track your health information online?; Daily; Weekly; Monthly; A few times a year; I don't use websites or applications for this. What device(s) do you use to access your personal health information online? (Please circle all that apply); Phone; Tablet; Laptop/desktop Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; -Various statements about PHI, electronic storage, and access-; Please rate how similar you are to Alex on the following dimensions: Gender Race Age Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; -Various questions about the virtual assistant's usefulness-	immediately after the intervention
Primary	Homophily	Homophily (Lin & Guan, 2003; McCroskey, Richmond, & Daly, 1975; Z. Wang, Walther, Pingree, & Hawkins, 2008) Alex, my healthcare assistant… 129. Thinks like me—doesn't think like me 130. Behaves like me—doesn't behave like me 131. Is similar to me—is different from me 132. Is like me—is unlike me 133. Has a background similar from mine—has a background different to mine 134. Has morals like mine—has morals unlike mine 135. Looks similar to me—looks different from me 136. Has the same body size as I do—is a different body size than I am	immediately after the intervention
Primary	Interpersonal Distance	Interpersonal Distance (Bailenson, Blascovich, Beall, & Loomis, 2003) Please indicate how strongly you agree or disagree with the following statements (5=strongly agree; 1=strongly disagree).; 137. I perceive that I am in the presence of Alex in the room with me. 138. I feel that Alex is aware of my presence. 139. The thought that Alex is not a real person crosses my mind often. 140. I perceive Alex as being only a computerized image, not as a real person.	immediately after the intervention