Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Screening, Prevention
Brief summary
Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence.
Detailed description
This two-armed randomized controlled trial (300 patients/arm) will compare Colorectal Web (CW), the interactive DA, to a non-interactive control website in ten practices in Metro Detroit. Patients will be adults aged 50 years and over, not current on CRCS. In the clinic before the patient-physician encounter, participants will complete a Patient Baseline Survey. They will be randomized to CW or the control website. Data will be collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording), and after it (Post-Encounter Survey). Chart audit will be performed six months after the encounter to determine whether the patient underwent CRCS.
Interventions
BEHAVIORALColorectal Web
The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 50-75 years of age * not current with colorectal cancer screening * scheduled for HME, Health Maintenance Exam, or chronic care visit with participating physician * able to read English * current contact information
Exclusion criteria
* history of colon cancer or adenomatous polyps * history of dementia or psychosis * contraindication to CRCS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits | 6 months following intervention a chart audit will be conducted to determine if CRCS was completed. | Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment. | 286 |
| Intervention With Colorectal Website Intervention website includes an interactive component including preferences and risk assessment.
Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS | 284 |
| Total | 570 |
Baseline characteristics
| Characteristic | Control | Intervention With Colorectal Website | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 55 Participants | 44 Participants | 99 Participants |
| Age, Categorical Between 18 and 65 years | 231 Participants | 240 Participants | 471 Participants |
| Age, Continuous | 58.3 years STANDARD_DEVIATION 6.9 | 57.1 years STANDARD_DEVIATION 6.8 | 57.7 years STANDARD_DEVIATION 6.9 |
| Participants screened for colon cancer | 111 Participants | 99 Participants | 210 Participants |
| Region of Enrollment United States | 286 Participants | 284 Participants | 570 Participants |
| Sex: Female, Male Female | 177 Participants | 143 Participants | 320 Participants |
| Sex: Female, Male Male | 109 Participants | 141 Participants | 250 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 286 | 1 / 284 |
| other Total, other adverse events | 0 / 286 | 0 / 284 |
| serious Total, serious adverse events | 0 / 286 | 1 / 284 |
Outcome results
Primary
Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits
Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening.
Time frame: 6 months following intervention a chart audit will be conducted to determine if CRCS was completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits | 111 participants |
| Intervention With Colorectal Website | Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits | 99 participants |