Patient Reminders Optimizing Mail-in Prevention Testing for Colorectal Cancer

NCT06710509 | Completed

• 1 other identifier: RAS20240016
• Study Type: interventional
• Target: 2,106
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer Screening

Keywords

colon cancer screening

Outcome Measures

Primary Outcomes (1)

• Percentage kit return at 4 weeks

  Percentage of patients who have Cologuard stool testing lab results returned 4 weeks after receiving the intervention

  4 weeks from date first message was sent

Secondary Outcomes (2)

• Percentage kit return at 8 weeks

  8 weeks from date first message was sent

• Percentage kit return at 12 weeks

  12 weeks from date first message was sent

Study Arms (2)

Control Group

NO INTERVENTION

Group not receiving the messages

Experimental Group

EXPERIMENTAL

Group receiving the messages

Behavioral: Three Messaging Nudges

Interventions

Three Messaging Nudges 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.

Experimental Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emily Rosenzweig: lead

Study Sites (1)

Ascension Health

St Louis, Missouri, 63134, United States

Location

Study Officials

• Emily Rosenzweig

  Ascension Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Behavioral Science

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: December 5, 2024
• Primary Completion: January 2, 2025
• Study Completion: February 26, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)