Patient Reminders Optimizing Mail-in Prevention Testing for Colorectal Cancer

NCT ID: NCT06710509

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-05
• Study Completion Date: 2025-02-26

Brief Summary

Screening is an important tool for early colorectal cancer detection, and the most recent evidence suggests that early detection significantly improves survival rates. Current medical guidelines recommend that all people aged 45 to 75 be screened regularly. However, actual rates of screening in the United States are much lower than this.

Colonoscopy is the gold standard in colon cancer screening, serving as both screening and prevention. However there are many barriers to colonoscopy uptake, including lack of awareness, patient reticence, scheduling complexity, and market variation in access. Stool testing is a valuable alternative to colonoscopy for low-risk patients. Exact Sciences is the company that makes Cologuard, which is the current best-in-class stool testing for colon cancer screening.

Despite being a convenient at-home screening option, patient engagement with screening via stool testing has room for improvement. Over 40% of Ascension patients who have a stool testing order placed for them never return the screening kit in the mail.

A large body of research demonstrates that interventions informed by behavioral science can support patients in engaging in a variety of preventative health behaviors. Personalized nudges have proven to be among the most effective types of interventions, along with interventions aimed at helping patients overcome barriers to screening. We aim to test whether behavioral nudges can increase stool testing kit return rates.

Detailed Description

Screening is an important tool for early colorectal cancer detection, and the most recent evidence suggests that early detection significantly improves survival rates. Current medical guidelines recommend that all people aged 45 to 75 be screened regularly. However, actual rates of screening in the United States are much lower than this, particularly among younger patient cohorts. Screening rates are still lower for patients who are "socially vulnerable" - a measure of the degree to which social and demographic factors make them vulnerable to health disparities.

Colonoscopy is the gold standard in colon cancer screening, serving as both screening and prevention. However there are many barriers to colonoscopy uptake, including lack of awareness, patient reticence, scheduling complexity, and market variation in access. Stool testing is a valuable alternative to colonoscopy for low-risk patients. Exact Sciences is the company that makes Cologuard, which is the current best-in-class stool testing for colon cancer screening.

Despite being a convenient at-home screening option, patient engagement with screening via stool testing has room for improvement. Over 40% of Ascension patients who have a stool testing order placed for them never return the screening kit in the mail.

A large body of research demonstrates that interventions informed by behavioral science can support patients in engaging in a variety of preventative health behaviors. Personalized nudges have proven to be among the most effective types of interventions, along with interventions aimed at helping patients overcome barriers to screening.4 We aim to test whether behavioral nudges can increase stool testing kit return rates.

Conditions

Colon Cancer Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Group not receiving the messages

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Group

Group receiving the messages

Group Type: EXPERIMENTAL

Three Messaging Nudges

Intervention Type: BEHAVIORAL

Patients in the Experimental Condition will receive a set of up to three email and text messages over the course of five days, while also receiving usual care which could include messaging from their practice or the electronic health record.

Interventions

Three Messaging Nudges

Patients in the Experimental Condition will receive a set of up to three email and text messages over the course of five days, while also receiving usual care which could include messaging from their practice or the electronic health record.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 45-75
• Have either a mobile phone number or an email address on file with the health system
• Included in and non-compliant on the Ascension Colon Cancer Screening Clinical Priority Goal measure.
• Have consented to receive electronic communications from the health system
• Ascension primary care provider placed an order for stool testing between 60 and 180 days prior to the intervention.
• No record of Cologuard stool testing lab results returned within 60 days of the order being placed.

Exclusion Criteria

• Patients whose primary care providers are exempted from the campaign by the health system
• Patients with a record of having been screened for colorectal cancer through some other method during the time since the initial order for Cologuard stool testing was placed.
• Have received a nudge campaign from the Clinical Transformation team in the past 90 days
• Patients who have previously opted out of receiving electronic communications from the health system in our message delivery platform (Salesforce)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emily Rosenzweig

INDUSTRY

Sponsor Role: lead

Responsible Party

Emily Rosenzweig

Director of Behavioral Science

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emily Rosenzweig

Role: PRINCIPAL_INVESTIGATOR

Ascension Health

Locations

Ascension Health

St Louis, Missouri, United States

Countries

United States

Other Identifiers

RAS20240016

Identifier Type: -

Identifier Source: org_study_id