N/A
N=1,111
Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Cancer Screening Tests
Bottom Line
View on ClinicalTrials.gov: NCT04683731 ↗Enrolled (actual)
1,111
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants Who Completed Colorectal Cancer Screening — 110; 95; 113; 113 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision aid without personalized message (Behavioral); Decision aid with personalized message (Behavioral); Provider notification without personalized message (Behavioral); Provider notification with personalized message (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed Colorectal Cancer Screening |
110; 95; 113; 113 | — |
| PRIMARY Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior. |
90; 92; 91; 103 | — |
| SECONDARY Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed |
59; 39; 52; 51; 51; 56 | — |
| SECONDARY Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit |
0.59; 0.68; 0.55; 0.63; 0.23; 0.24 | — |
| SECONDARY Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior |
70; 58; 56; 79; 62; 53 | — |
| SECONDARY Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit. |
3.65; 3.70; 3.75; 3.76; -0.60; -0.58 | — |
| SECONDARY Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit |
0.21; 0.15; 0.14; 0.08; -0.10; 0.12 | — |
| SECONDARY Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit |
-36.6; -42.4; -37.1; -40.3; -1.60; -0.76 | — |
| SECONDARY Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4 |
203; 178; 164; 201; 26; 28 | — |
| SECONDARY Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument |
152; 134; 130; 159; 76; 72 | — |
| SECONDARY Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE |
6.4; 6.3; 6.3; 6.5 | — |
| SECONDARY Number of Participants With Orders for a Colorectal Cancer Screening (CRC) Test |
89; 84; 79; 84; 201; 178 | — |
| SECONDARY Number of Providers Who Open Their Provider Notification |
181; 161; 153; 175; 34; 33 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04683731). 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.