N/A
N=825
Shared Decision-Making for Colorectal Cancer Screening
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00251862 ↗Enrolled (actual)
825
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Patient Adherence (Test Completion) — 104; 116; 96 participants — p=0.046
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Web-based decision aid plus personalized risk assessment (Behavioral); Web-based decision aid alone (Behavioral); Generic website (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Adherence (Test Completion) |
104; 116; 96 | 0.046 sig |
| SECONDARY Patient Knowledge |
10.7; 10.9; 8.6 | <0.001 sig |
| SECONDARY Patient Satisfaction With Decision Making Process |
49.0; 49.7; 45.5 | <0.001 sig |
| SECONDARY Screening Intentions |
4.4; 4.4; 4.0 | <0.001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00251862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.