Clinical trial NCT04683731: Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Official title: Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Screening Tests
Keywords: decision aid
cancer screening
risk assessment
risk communication
colorectal neoplasm
decision making
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-12-24
Enrollment: 1111
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2x2, randomized, controlled trial
Primary purpose: SCREENING

Brief 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.

Detailed description: The research team has developed and pilot tested a decision aid and provider message that discloses the patient's current risk of ACN, based on a prediction rule developed and validated by Dr. Thomas Imperiale, a member of the study team. The Imperiale Prediction Rule uses five variables (gender, age, CRC family history, waist circumference, and smoking history) and identifies a wide range of risk for current ACN among average risk patients. For patients with "high-average" risk (22%), personalized messages in the decision aid and provider notification highlight the advantage of colonoscopy because of the likelihood of finding and removing an ACN. For patients at low risk for ACN (2% or 4%), personalized messages highlight the advantage of stool testing, due to the relatively low chance of failing to detect ACN.

The investigators' long-term goal is to increase uptake of CRC screening by informing and improving patient and provider discussion and decisions. The main objective of this project is to test whether providing patients and their providers with personalized messages about ACN risk results in higher screening uptake and higher decision quality, compared to an approach that does not utilize ACN risk.

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.

Primary outcomes:
measure: Number of Participants Who Completed Colorectal Cancer Screening
timeFrame: 6 months after patient enrollment
measure: Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.
timeFrame: 6 months after participant enrollment
Secondary outcomes:
measure: Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed
timeFrame: 6 months after participant enrollment
measure: Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
timeFrame: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
measure: Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
timeFrame: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
measure: Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.
timeFrame: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
measure: Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
timeFrame: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
measure: Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
timeFrame: 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
measure: Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
timeFrame: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
measure: Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument
timeFrame: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
measure: Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE
timeFrame: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
measure: Number of Participants With Orders for a Colorectal Cancer Screening (CRC) Test
timeFrame: 6 months after patient enrollment
measure: Number of Providers Who Open Their Provider Notification
timeFrame: 6 months after patient enrollment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Peter H. Schwartz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: