Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

NCT05693649 | Active Not Recruiting DMC

• 1 other identifier: UPCC 14022
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 3-year pragmatic, randomized clinical trial among average-risk patients at diverse primary care practices who are overdue for colorectal (CRC) screening. This project aims to evaluate the effect of a centralized program that includes direct outreach to patients and visit-based, clinician directed nudges facilitated by the electronic health record (EHR) with follow-up text messaging on the uptake of CRC screening. The primary outcome is CRC screening completion at 3 years. Patient and clinician factors impacting the experience and effectiveness of the intervention will be explored through surveys and qualitative interviews.

Conditions

Colorectal Cancer

Keywords

Prevention; Cancer Screening; Behavioral Economics

Outcome Measures

Primary Outcomes (1)

• CRC screening completion at 3 years

  CRC screening completion at 3 years, which could be satisfied by any one of the following: colonoscopy completion at any time, negative FIT completed 2 times, or positive FIT followed by diagnostic colonoscopy within 1 year.

  3 years

Secondary Outcomes (2)

• CRC screening rate

  3 years

• Choice of test

  3 years

Study Arms (5)

Arm 1A: Usual Care

EXPERIMENTAL

Patients assigned to the Usual Care arm will receive current usual care and will not receive direct patient outreach or any visit-based interventions from this trial.

Behavioral: No Direct Patient Outreach; Behavioral: No Nudge/Text

Arm 2A: Colonoscopy Only and No Nudge/Text

EXPERIMENTAL

Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. Patients randomized to this arm will not receive visit-based interventions.

Behavioral: Direct Patient Outreach: Colonoscopy Only; Behavioral: No Nudge/Text

Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text

EXPERIMENTAL

Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. Patients randomized to this arm who attend a visit with their Primary Care Physician (PCP) will additionally receive a visit-based, clinician directed nudge to discuss colorectal cancer screening and a follow-up text 3 days post-visit to encourage screening completion.

Behavioral: Direct Patient Outreach: Colonoscopy Only; Behavioral: Visit-Based Nudge/Text

Arm 3A: Sequential Choice and No Nudge/Text

EXPERIMENTAL

Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. If not completed, patients will receive an order and a mailed fecal immunochemical test (FIT) with a reminder to complete CRC screening. Patients randomized to this arm will not receive visit-based interventions.

Behavioral: Direct Patient Outreach: Sequential Choice; Behavioral: No Nudge/Text

Arm 3B: Sequential Choice and Visit-Based Nudge/Text

EXPERIMENTAL

Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. If not completed, patients will receive an order and a mailed fecal immunochemical test (FIT) with a reminder to complete CRC screening. Patients randomized to this arm who attend a visit with their Primary Care Physician (PCP) will additionally receive a visit-based, clinician directed nudge to discuss colorectal cancer screening and a follow-up text 3 days post-visit to encourage screening completion.

Behavioral: Direct Patient Outreach: Sequential Choice; Behavioral: Visit-Based Nudge/Text

Interventions

No Direct Patient Outreach BEHAVIORAL

Patient will not receive direct outreach prompting them to schedule and/or complete colorectal cancer screening.

Arm 1A: Usual Care

Direct Patient Outreach: Colonoscopy Only BEHAVIORAL

Patient will receive direct outreach including an order to schedule and complete colonoscopy.

Arm 2A: Colonoscopy Only and No Nudge/Text; Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text

Direct Patient Outreach: Sequential Choice BEHAVIORAL

Patient will receive direct outreach including an order to schedule and complete colonoscopy then an at-home fecal immunochemical test (FIT) if colonoscopy is not completed.

Arm 3A: Sequential Choice and No Nudge/Text; Arm 3B: Sequential Choice and Visit-Based Nudge/Text

Visit-Based Nudge/Text BEHAVIORAL

Patient's clinician will receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will also receive a text message 3 days after visit reminding them to complete colorectal cancer screening.

Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text; Arm 3B: Sequential Choice and Visit-Based Nudge/Text

No Nudge/Text BEHAVIORAL

Patient's clinician will not receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will not receive a text message 3 days after visit reminding them to complete colorectal cancer screening.

Arm 1A: Usual Care; Arm 2A: Colonoscopy Only and No Nudge/Text; Arm 3A: Sequential Choice and No Nudge/Text

Eligibility Criteria

• Age: 50 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ages 50-72
• Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
• Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, MT-sDNA in the last 3 years).

You may not qualify if:

• Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease
• History of total colectomy, dementia or metastatic cancer
• Currently on hospice or receiving palliative care
• Uninsured or self-pay patients
• Currently scheduled for a colonoscopy or sigmoidoscopy
• Active order for multitarget stool DNA testing (MT-sDNA)
• History of paraplegia or quadriplegia
• Elevated chance of mortality within 3 years according to mortality risk algorithm
• Active order for Fecal Immunochemical Test (FIT) in the last 60 days
• Positive stool test (FIT or MT-sDNA) result in the last 5 years

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Mehta SJ, Shaw PA, Reitz C, Brophy C, Okorie E, Williams K, Segura A, Tao J, Snider CK, Wollack C, Friday S, Rendle KA, Klaiman T, Glanz K, Rhodes C, Asch DA. Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic randomized clinical trial. Contemp Clin Trials. 2025 Dec 16;161:108188. doi: 10.1016/j.cct.2025.108188. Online ahead of print.

  PMID: 41412475 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Shivan Mehta, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: June 7, 2023
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)