Clinical trial · Interventional
FIT Mailing Protocol-For Cancer Screening Navigation
- 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)
We plan to study whether the impact of offering the choice of a pre-colonoscopy physician visit or direct referral to colonoscopy will increase adherence to colonoscopy relative to usual care in a large fecal immunochemical test (FIT) mailing campaign. We will evaluate two study options, usual care during which patients will be required to have an office visit with wither a PCP or a Gastroenterologist prior to being scheduled for a colonoscopy, or a choice where patients will be given the option of a pre-colonoscopy visit with a gastroenterologist or PCP vs. direct referral for a colonoscopy. In these two options we will examine colonoscopy adherence, adequacy of triage, patient satisfaction, colonoscopy outcomes (no show rate, prep quality, and pain during colonoscopy) and how insurance coverage, gender, race, education or patient understanding of colon cancer screening message during the navigation process might impact outcomes.
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colon Cancer Screening Navigation | Behavioral | — | UNRESOLVED |
| Standard of Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FIT Positive
- description
- Referral to GI or Primary Care. Patients will be referred to MD for pre-colonoscopy vist.Standard of Care.
- interventionNames
- Behavioral: Standard of Care
- type
- EXPERIMENTAL
- label
- FIT Positive Choice
- description
- Offered Chioce of Direct referral. Patients will be given a choice to advance to directly having a colonoscopy screening.Colon Cancer Screening Navigation.
- interventionNames
- Behavioral: Colon Cancer Screening Navigation
Primary outcomes (1)
- measure
- Colonoscopy Completion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Participants that have not had a colonoscopy with in 10 years, flexible sigmoidoscopy with in 5 years, or a stool for occult blood with in 1 year. Exclusion Criteria: * History of colon cancer, inflammatory bowel disease or colon polyps.
References
Publications (0)
Data not yet available