Clinical trial · Interventional
Shared Decision-Making for Colorectal Cancer Screening
NCT00251862CI-TRIAL-00013238completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Generic website | Behavioral | — | UNRESOLVED |
| Web-based decision aid alone | Behavioral | — | UNRESOLVED |
| Web-based decision aid plus personalized risk assessment | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Decision aid plus YourDiseaseRisk
- description
- Patients viewed the decision aid and completed the Your Disease Risk risk assessment tool prior to visit with their primary care provider.
- interventionNames
- Behavioral: Web-based decision aid plus personalized risk assessment
- type
- EXPERIMENTAL
- label
- Decision aid alone
- description
- Patient's viewed decision aid only prior to a visit with their primary care provider.
- interventionNames
- Behavioral: Web-based decision aid alone
- type
- SHAM_COMPARATOR
- label
- III
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDSchroy PC 3rd, Glick JT, Robinson PA, Lydotes MA, Evans SR, Emmons KM. Has the surge in media attention increased public awareness about colorectal cancer and screening? J Community Health. 2008 Feb;33(1):1-9. doi: 10.1007/s10900-007-9065-5. PMID 18080203
- BACKGROUNDSchroy PC 3rd, Glick JT, Robinson P, Lydotes MA, Heeren TC, Prout M, Davidson P, Wong JB. A cost-effectiveness analysis of subject recruitment strategies in the HIPAA era: results from a colorectal cancer screening adherence trial. Clin Trials. 2009 Dec;6(6):597-609. doi: 10.1177/1740774509346703. Epub 2009 Nov 23. PMID 19933718
- BACKGROUNDSchroy PC 3rd, Mylvaganam S, Davidson P. Provider perspectives on the utility of a colorectal cancer screening decision aid for facilitating shared decision making. Health Expect. 2014 Feb;17(1):27-35. doi: 10.1111/j.1369-7625.2011.00730.x. Epub 2011 Sep 8. PMID 21902773
- RESULTSchroy PC 3rd, Emmons K, Peters E, Glick JT, Robinson PA, Lydotes MA, Mylvanaman S, Evans S, Chaisson C, Pignone M, Prout M, Davidson P, Heeren TC. The impact of a novel computer-based decision aid on shared decision making for colorectal cancer screening: a randomized trial. Med Decis Making. 2011 Jan-Feb;31(1):93-107. doi: 10.1177/0272989X10369007. Epub 2010 May 18. PMID 20484090
- RESULTSchroy PC 3rd, Emmons KM, Peters E, Glick JT, Robinson PA, Lydotes MA, Mylvaganam SR, Coe AM, Chen CA, Chaisson CE, Pignone MP, Prout MN, Davidson PK, Heeren TC. Aid-assisted decision making and colorectal cancer screening: a randomized controlled trial. Am J Prev Med. 2012 Dec;43(6):573-83. doi: 10.1016/j.amepre.2012.08.018. PMID 23159252