N/A
Completed N=800
Engaging Patients in Colon Cancer Screening Decisions During COVID-19
Source: ClinicalTrials.gov NCT04548531 ↗Enrolled (actual)
800
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Shared Decision Making (SDM) Process Scale Score — 0.27; 0.95 Score on a scale of 0-4 — p=<.001
Summary
The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patients (n=800) will be randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to measure shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will conduct medical chart review to track receipt of colon cancer screening within 6 months. The statistician will test whether patients in the intervention arm report more shared decision making, less decisional conflict, higher intention to follow through on screening and have higher screening rates compared to those in the control arm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Shared Decision Making (SDM) Process Scale Score |
0.27; 0.95 | <.001 sig |
| SECONDARY No Decisional Conflict (Number With Score of 4 on SURE Scale) |
52; 73 | 0.003 sig |
| SECONDARY Patient's Preferred Approach to Screening |
78; 76; 42; 36 | .75 |
| SECONDARY Number Reporting "Very Likely" to Follow Through With Screening |
87; 94 | 0.14 |
| SECONDARY Colon Cancer Screening Rate |
91; 140 | <.001 sig |
Eligibility Criteria
Inclusion Criteria
- Adults, age 45-75
- Had screening or surveillance colonoscopy delayed or cancelled from March-June 2020
Exclusion Criteria
- Diagnostic colonoscopy
- High risk for colorectal cancer as indicated by 1 year follow up schedule
- Prior history of colon cancer
- Unable to read or write in English or Spanish
- Have already scheduled or completed a colonoscopy since restrictions were lifted
Data sourced from ClinicalTrials.gov (NCT04548531). 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. Informational only — not medical advice.