N/A
N=728
Information With or Without Numbers For Optimizing Reasoning About Medical Decisions
Colorectal Cancer Screening
Bottom Line
View on ClinicalTrials.gov: NCT02477553 ↗Enrolled (actual)
728
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Colorectal Cancer (CRC) Screening Completion — 99; 99 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DA - Quantitative (Behavioral); DA - Verbal (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Colorectal Cancer (CRC) Screening Completion |
99; 99 | — |
| PRIMARY Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention |
0.37; 0.47 | — |
| SECONDARY Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention |
-0.08; 0.08 | — |
| SECONDARY Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention |
0.44; 0.47; 0.44; 0.52 | — |
| SECONDARY Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention |
-0.18; -0.13; -0.18; -0.21 | — |
| SECONDARY Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention |
3.13; 3.66 | — |
| SECONDARY Decision Conflict: Change in Conflict From Baseline to Post-intervention |
-19.3; -22.0 | — |
| SECONDARY Number of Patients With High and Low Subjective Numeracy |
172; 160; 164; 177 | — |
Summary
Experts believe that increasing the low uptake of screening for colorectal cancer (CRC) requires educating patients about all approved tests and helping them choose one that fits their preferences. As one motto puts it: "The best test is the one that gets done." Screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how best to educate patients about the options and the tradeoffs involved. Some guidelines recommend that decision aids, a promising tool in this area, provide patients with detailed quantitative information, including baseline risk, risk reduction, and chance of negative outcomes. But this sort of "comparative effectiveness" data can confuse patients, especially those with limited mathematical ability. Previous studies have not measured the effect of providing quantitative information to patients with varying levels of ability or interest or asked them whether such data is essential for their decision-making.
The investigators will conduct a clinical trial to determine the impact on patients who view a decision aid (DA) that includes quantitative information versus a DA without such data. The investigators will also seek to determine whether numeracy moderates the effect of quantitative information.
Eligibility Criteria
Inclusion Criteria
- Have not had colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year and
- have a scheduled appointment or due to schedule an appointment with a healthcare practitioner at our performance sites.
Exclusion Criteria
- undergoing workup for symptoms consistent with colon cancer, such as weight loss or rectal bleeding
- have a diagnosis or medical history conferring elevated risk for CRC including polypectomy or colon cancer, inflammatory bowel disease, certain inherited syndromes, or a significant family history of CRC
- are unable to speak and read English.
Data sourced from ClinicalTrials.gov (NCT02477553). 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.