Colorectal Cancer
Conditions
Keywords
Colorectal cancer screening, Shared decision-making, Decision aid
Brief summary
The overall objective of this study is to conduct a three-arm randomized controlled trial to evaluate the impact of an interactive, web-based decision aid on shared decision-making and patient adherence to colorectal cancer (CRC) screening recommendations.
Detailed description
Colorectal cancer (CRC) is the second leading cause of cancer-related death and third most commonly diagnosed cancer among men and women in the United States. Screening has been shown to be a cost-effective strategy for reducing both CRC mortality through early detection and incidence through the detection and removal of precancerous adenomatous polyps (adenomas). Despite a compelling rationale and widespread endorsement by authoritative groups, screening rates remain far below those necessary to achieve significant reductions in CRC mortality or incidence. Poor patient acceptance and non-adherence to screening recommendations are partly responsible for low screening rates. Shared decision-making has been advocated as a potentially effective yet unproven strategy for addressing this problem. Implicit in this approach is the need for an unbiased decision aid that not only educates patients about the pros and cons of the different strategies so as to enable them to identify a preferred strategy but also empowers patients to take a proactive role in the decision-making process, thereby increasing satisfaction and promoting adherence. From a logistical standpoint, the decision aid must also be easy to implement in the ambulatory setting so as to maximize use but minimize demands on physician time and office resources. To address this need, we have developed an interactive, web-based decision aid and implementation strategy for use in routine clinical practice. Comparison(s): Average risk subjects assigned to one of two intervention arms (decision aid alone versus decision aid plus personalized risk assessment with feedback) compared to a control arm(generic website that discusses lifestyle changes that can reduce overall cancer risk).
Interventions
BEHAVIORALWeb-based decision aid plus personalized risk assessment
Patients review a computer-based decision aid that discuss the pros and cons of of 5 recommended CRC screening options and provides personalized 10-year estimates of CRC risk prior to meeting with their provider to discuss CRC screening.
BEHAVIORALWeb-based decision aid alone
Patients review a computer-based decision aid that discuss the pros and cons of the 5 recommended CRC screening options prior to meeting with their provider to discuss CRC screening.
BEHAVIORALGeneric website
Patients review a generic website that discuss ways to reduce overall cancer risk.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Asymptomatic average-risk subjects * Under the direct care of one of participating site's staff (attending) physicians or physician extenders; * No prior screening other than fecal occult blood testing (FOBT); * No major co-morbidities that preclude CRC screening by any method
Exclusion criteria
* Prior CRC screening by any method other than FOBT occult blood testing * High-risk condition (personal history of colorectal cancer or polyps, family history of colorectal cancer or polyps involving one or more first degree relatives, chronic inflammatory bowel disease) * Lack of fluency in written and spoken English (since decision aid and personalized risk assessment tool will be in English only due to funding issues); * Comorbidities that preclude CRC screening by any method
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Adherence (Test Completion) | 12 months post-intervention | Completion of a screening test within 12 months of the study visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Knowledge | Immediate post-intervention study visit | Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don't know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions. |
| Patient Satisfaction With Decision Making Process | Immediate post-intervention primary care provider (PCP) visit | Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for strongly disagree (or poor) to 5 for strongly agree (or excellent). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data. |
| Screening Intentions | Immediate post-intervention study visit | Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for not at all sure to 5 for completely sure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DA + YDR Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback | 280 |
| DA Alone Decision aid alone | 269 |
| Control Standard Care | 276 |
| Total | 825 |
Baseline characteristics
| Characteristic | Control | DA + YDR | DA Alone | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 46 Participants | 48 Participants | 35 Participants | 129 Participants |
| Age, Categorical Between 18 and 65 years | 230 Participants | 232 Participants | 234 Participants | 696 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 18 Participants | 10 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 261 Participants | 262 Participants | 259 Participants | 782 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 180 Participants | 172 Participants | 160 Participants | 512 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
| Race (NIH/OMB) White | 88 Participants | 99 Participants | 96 Participants | 283 Participants |
| Region of Enrollment United States | 276 participants | 280 participants | 269 participants | 825 participants |
| Sex: Female, Male Female | 159 Participants | 163 Participants | 164 Participants | 486 Participants |
| Sex: Female, Male Male | 117 Participants | 117 Participants | 105 Participants | 339 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 280 | 0 / 269 | 0 / 276 |
| serious Total, serious adverse events | 0 / 280 | 0 / 269 | 0 / 276 |
Outcome results
Primary
Patient Adherence (Test Completion)
Completion of a screening test within 12 months of the study visit.
Time frame: 12 months post-intervention
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DA + YDR | Patient Adherence (Test Completion) | 104 participants |
| DA Alone | Patient Adherence (Test Completion) | 116 participants |
| Control | Patient Adherence (Test Completion) | 96 participants |
Comparison: Sample size and power considerations focused on a two-group comparison of the DA alone versus control study arms for the primary outcome of colorectal cancer (CRC) screening test completion at 12 months. Based on crude estimates of baseline test completion rates, we calculated that a target sample of 275 subjects per arm provided greater than 80% power of detecting a 54% vs. 40% difference at the P\<0.05 level.p-value: 0.04695% CI: [-2.2, 14.2]Chi-squared
p-value: 0.15395% CI: [0.2, 16.5]Chi-squared
Secondary
Patient Knowledge
Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don't know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.
Time frame: Immediate post-intervention study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DA + YDR | Patient Knowledge | 10.7 units on a scale | Standard Deviation 1.9 |
| DA Alone | Patient Knowledge | 10.9 units on a scale | Standard Deviation 1.6 |
| Control | Patient Knowledge | 8.6 units on a scale | Standard Deviation 2.6 |
Comparison: The three study groups were compared on cumulative pre-test and post-test knowledge through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.p-value: <0.001ANCOVA
Secondary
Patient Satisfaction With Decision Making Process
Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for strongly disagree (or poor) to 5 for strongly agree (or excellent). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data.
Time frame: Immediate post-intervention primary care provider (PCP) visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DA + YDR | Patient Satisfaction With Decision Making Process | 49.0 units on a scale | Standard Deviation 6.2 |
| DA Alone | Patient Satisfaction With Decision Making Process | 49.7 units on a scale | Standard Deviation 6.4 |
| Control | Patient Satisfaction With Decision Making Process | 45.5 units on a scale | Standard Deviation 7.8 |
Comparison: The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.p-value: <0.001ANCOVA
Secondary
Screening Intentions
Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for not at all sure to 5 for completely sure.
Time frame: Immediate post-intervention study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DA + YDR | Screening Intentions | 4.4 units on a scale | Standard Deviation 1 |
| DA Alone | Screening Intentions | 4.4 units on a scale | Standard Deviation 1 |
| Control | Screening Intentions | 4.0 units on a scale | Standard Deviation 1.3 |
Comparison: The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.p-value: <0.001ANCOVA