Colo-rectal Cancer
Conditions
Brief summary
The purpose of this proposal is to test the efficacy of a patient-centered, tailored message intervention delivered via virtual technology for increasing colorectal cancer (CRC) screening within guidelines among racial/ethnic minority and rural patients. This protocol focuses on the clinical portion of grant NCI 1RCA207689-01A1
Detailed description
Patients will be recruited via a secure, clinical data warehouse to complete a patient-randomized test of the efficacy of the intervention for promoting initial and repeat FIT testing. Patients identified as eligible will be contacted through MyChart to test a web-based, culturally-sensitive virtual human intervention for CRC screening. The web-application will provide information to encourage CRC screening. Therefore, this study is a minimal risk study.
Interventions
OTHERvirtual technology
The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.
Sponsors
National Cancer Institute (NCI)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
Study Team will recruit an ethnically diverse sample of eligible patients to complete the intervention.
Eligibility
Sex/Gender
ALL
Age
45 Years to 73 Years
Healthy volunteers
Yes
Inclusion criteria
* able to read English or Spanish at least at eighth-grade level * have an email account or the ability to receive texts * willingness to be re-contacted * consent to MRR related to CRC screening * not remember completing any CRC screening within recommended guidelines (i.e., \<10 years for colonoscopy, \<1 year for stool test). * complete a FIT test: * a) with a negative result only * b) complete a FIT test with a positive result AND undergo a completion screening colonoscopy, * Or c) complete a colonoscopy only.
Exclusion criteria
* unable to read English at least at eighth-grade level * doesn't have an email account or the ability to receive texts * unwilling to be re-contacted * Unable to consent to MRR related to CRC screening * have not had \<10 years for colonoscopy, or 1 year for stool test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention to Screen for Colorectal Cancer (CRC) | within the first 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Communication With a Provider About Colorectal Cancer (CRC) | Assessed after 24 months | Measure: Intention to talk to doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: I will talk to my healthcare provider about colorectal cancer screening. 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Human (VH) Screening Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements.
virtual technology - highly tailored VH: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs. The VH-tailored content was presented using an animated computer-generated character to deliver tailored, culturally aligned health messages about CRC screening. | 473 |
| Text-Based (TB) Screening Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements.
virtual technology - tailored minimally TB: The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Minimally tailored patient reminders will be customized using 4 randomly selected constructs. The TB-tailored content was presented using an image of a computer-generated character to deliver tailored, culturally aligned health messages about CRC screening. | 470 |
| Total | 943 |
Baseline characteristics
| Characteristic | Virtual Human (VH) Screening | Text-Based (TB) Screening | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 92 Participants | 111 Participants | 203 Participants |
| Age, Categorical Between 18 and 65 years | 381 Participants | 359 Participants | 740 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 26 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 425 Participants | 411 Participants | 836 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 33 Participants | 54 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 196 Participants | 205 Participants | 401 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 13 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 32 Participants | 54 Participants |
| Race (NIH/OMB) White | 240 Participants | 212 Participants | 452 Participants |
| Sex/Gender, Customized Female | 324 Participants | 302 Participants | 626 Participants |
| Sex/Gender, Customized Male | 135 Participants | 142 Participants | 277 Participants |
| Sex/Gender, Customized Sex not reported | 14 Participants | 26 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 473 | 0 / 470 |
| other Total, other adverse events | 0 / 473 | 0 / 470 |
| serious Total, serious adverse events | 0 / 473 | 0 / 470 |
Outcome results
Primary
Intention to Screen for Colorectal Cancer (CRC)
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: within the first 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Human (VH) | Intention to Screen for Colorectal Cancer (CRC) | 4.33 units on a scale | Standard Deviation 0.94 |
| Text-Base (TB) | Intention to Screen for Colorectal Cancer (CRC) | 4.45 units on a scale | Standard Deviation 0.86 |
Secondary
Communication With a Provider About Colorectal Cancer (CRC)
Measure: Intention to talk to doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: I will talk to my healthcare provider about colorectal cancer screening. 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: Assessed after 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Human (VH) | Communication With a Provider About Colorectal Cancer (CRC) | 4.32 units on a scale | Standard Deviation 0.91 |
| Text-Base (TB) | Communication With a Provider About Colorectal Cancer (CRC) | 4.33 units on a scale | Standard Deviation 0.9 |