Clinical trial · Interventional
Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
NCT04683731CI-TRIAL-00083726completedN/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)
Precision prevention holds great promise for colorectal cancer (CRC) screening but has not been adequately explored. A patient's chance of having an advanced colorectal neoplasm (ACN), i.e. a cancer or precancerous polyp in the colon, significantly affects the comparative effectiveness of approved tests. Giving patients a decision aid with information about their risk for ACN, and giving their providers similar information, could help patients and providers decide if colonoscopy or a non-invasive test (such as the fecal immunochemical test) is more appropriate. This could improve decision making and increase uptake of CRC screening, which are the investigative team's long-term goals.
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 |
|---|---|---|---|
| Cancer Screening Tests | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision aid without personalized message | Behavioral | — | UNRESOLVED |
| Decision aid with personalized message | Behavioral | — | UNRESOLVED |
| Provider notification without personalized message | Behavioral | — | UNRESOLVED |
| Provider notification with personalized message | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- Patients view decision aid without personalized message and whose providers do not receive the personalized message.
- interventionNames
- Behavioral: Decision aid without personalized message
- Behavioral: Provider notification without personalized message
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Patients view decision aid with personalized message and whose providers do not receive the personalized message.
- interventionNames
- Behavioral: Decision aid with personalized message
- Behavioral: Provider notification without personalized message
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: PATIENTS will be eligible if they are: * age 50 - 75 years * have not had a colonoscopy performed in the last 10 years, sigmoidoscopy in the last 5 years, fecal occult blood testing (FOBT or FIT) in the last year, or Cologuard in the last 3 years * have not had a colonoscopy since turning 50 years old * have a scheduled appointment with a provider who agreed to participate in the study PROVIDERS will be eligible if they are: * a physician (MD or DO), nurse practitioner (NP), or physicians assistant (PA) practicing at a partner research site Exclusion Criteria: PATIENTS will be excluded if they are: * undergoing workup for symptoms consistent with CRC, such as unexplained weight loss, change in bowel habit, or rectal bleeding * have a diagnosis or medical history conferring elevated risk for CRC including a previous adenomatous polyp or CRC, inflammatory bowel disease, high-risk syndromes, or a significant family history of CRC (two or more first degree relatives (FDR) with CRC or one FDR with a CRC diagnosis prior to age 60) * are unable to speak and read English * previously participated in any research projects regarding colorectal cancer screening or colonoscopy including, but not limited to the investigators' previous studies * members of the study team will not be participating in the study; therefore, patients who have a scheduled appointment with any member of the study team will not be eligible. PROVIDERS will be excluded if they: * do not have patients between 50 - 75 years old.
References
Publications (2)
- DERIVEDSchwartz PH, Imperiale TF, Perkins SM, Schmidt KK, Althouse S, Rawl SM. Effect of Personalized Risk Messages on Patient Intent and Decision Making in Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2026 Jul 28:272989X261455045. doi: 10.1177/0272989X261455045. Online ahead of print. PMID 42517432
- DERIVEDSchwartz PH, Perkins SM, Rawl SM, Schmidt KK, Althouse S, Imperiale TF. Effect of Personalized Risk Messages on Uptake of Colorectal Cancer Screening : A Randomized Controlled Trial. Ann Intern Med. 2025 Oct;178(10):1390-1399. doi: 10.7326/ANNALS-24-03144. Epub 2025 Sep 2. PMID 40889370