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OpenTrials
Completed

NCT Number: NCT06710509

Patient Reminders Optimizing Mail-in Prevention Testing for Colorectal Cancer

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ascension Health

St Louis, Missouri, 63134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Percentage kit return at 4 weeks

    Time frame: 4 weeks from date first message was sent

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

Secondary outcomes

  1. Percentage kit return at 8 weeks

    Time frame: 8 weeks from date first message was sent

    Percentage of patients who have Cologuard stool testing lab results returned 8 weeks after receiving the intervention

  2. Percentage kit return at 12 weeks

    Time frame: 12 weeks from date first message was sent

    Percentage of patients who have Cologuard stool testing lab results returned 12 weeks after receiving the intervention

Sponsors and collaborators

Lead sponsor

Laura Feemster

Industry

Registry information

Acronym: PROMPT-CRC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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