Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

Indiana University

Status: Completed

Conditions: Cancer Screening Tests

Treatments: Behavioral: Provider notification with personalized message; Behavioral: Decision aid without personalized message; Behavioral: Provider notification without personalized message; Behavioral: Decision aid with personalized message

Study type: Interventional

Funder types: Other

Identifiers

NCT04683731

CDR-2018C3-14715 (Other Grant/Funding Number)

2004109966

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,111 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,111 participants in 4 patient groups

Group 1

Active Comparator group

Description:

Patients view decision aid without personalized message and whose providers do not receive the personalized message.

Treatment:

Behavioral: Provider notification without personalized message

Behavioral: Decision aid without personalized message

Group 2

Experimental group

Description:

Patients view decision aid with personalized message and whose providers do not receive the personalized message.

Treatment:

Behavioral: Provider notification without personalized message

Behavioral: Decision aid with personalized message

Group 3

Experimental group

Description:

Patient view decision aid without the personalized message and whose providers receive the personalized message.

Treatment:

Behavioral: Decision aid without personalized message

Behavioral: Provider notification with personalized message

Group 4

Experimental group

Description:

Patients view decision aid with the personalized message and whose providers receive the personalized message.

Treatment:

Behavioral: Decision aid with personalized message

Behavioral: Provider notification with personalized message