Clinical trial · Interventional
Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
NCT02929186CI-TRIAL-00045237completedN/AClinicalTrials.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)
This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).
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 of the Colon | Malignant Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Opt-In Outreach | Behavioral | — | UNRESOLVED |
| Opt-Out Outreach | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Opt-In
- description
- Opt-In Outreach
- interventionNames
- Behavioral: Opt-In Outreach
- type
- EXPERIMENTAL
- label
- Opt-Out
- description
- Opt-Out Outreach
- interventionNames
- Behavioral: Opt-Out Outreach
Primary outcomes (1)
- measure
- FIT Completion Rate
- timeFrame
- 3 months
- description
- The percentage of participants who successfully complete the FIT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Between 50 to 74 years old * Has received care at the Division of Internal Medicine * Due for screening * Asymptomatic for colorectal cancer (CRC) Exclusion Criteria: * Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures) * Has a history of CRC * Has a history of other GI cancer * Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients) * Has history of colitis other than Crohn's disease or ulcerative colitis * Has had a colectomy * Has a relative that has been diagnosed with CRC * Has been diagnosed with Lynch Syndrome (i.e. HNPCC) * Has been diagnosed with Familial Adenomatous Polyposis (FAP) * Has iron deficiency anemia * Has history of lower GI bleeding * Has metastatic (Stage IV) blood or solid tumor cancer * Has end stage renal disease * Has cirrhosis * Has heart failure * Has dementia * Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
References
Publications (0)
Data not yet available
No reference posted for this study.