Nudge Strategies for DPYD Testing in Patients With Gastrointestinal Cancers Treated With Fluoropyrimidines (DPYD Nudges)

November 20, 2025 updated by: Abramson Cancer Center at Penn Medicine

Optimizing Nudge Strategies to Increase the Adoption of DPYD Testing in Patients With Gastrointestinal (GI) Malignancies Treated With Fluoropyrimidines.

5-fluorouracil and capecitabine, sometimes called 5-FU, fluoropyrimidines, or Xeloda are a type of chemotherapy. Many people have side effects from these drugs like nausea, diarrhea, or blood problems. This research study is being conducted to learn how to help increase the number of patients offered DPYD testing before taking this type of chemotherapy drugs. DPYD testing can help predict risk of side effects.

Different people's bodies break down and use drugs faster or slower. Genes are the instructions that tell our bodies how to do this. The DPYD gene is one of the genes that tell your body how to use chemotherapy drugs. Some people have changes in their DPYD gene that can make their side effects from chemotherapy worse, sometimes so bad that they die. DPYD testing can tell doctors which people have these gene changes and need extra monitoring during chemotherapy.

Some of the people in this study will join a focus group and read sample messages for future patients. They will discuss with the other participants how well the message does its job and anything that might make the message better. When there are no more messages, the host may ask about other information for future patients like a website or brochure.

Other people in the study will read sample messages that may be sent to future patients about DPYD testing. They will select the message that they like the best and might make them ask their oncologist about testing options.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION AND PURPOSE:

Fluoropyrimidines (FPs) are the cornerstone of treatment for several gastrointestinal (GI) malignancies. Approximately 5-7% of patients carry reduced function variants in DPYD, resulting in the inability to metabolize FPs, predisposing them to severe, life-threatening toxicities. These patients can be identified through DPYD pharmacogenetic (PGx) testing. However, DPYD testing has not been widely adopted in clinical care due to implementation barriers at the system- (e.g., access to testing, integration into clinical workflows), clinician- (e.g., interpretation of results, remembering to order test) and patient- (e.g., knowledge about testing, worry about adverse effects of testing) levels. This results in substantial uncertainty and a tendency to rely on several biases [e.g., status quo (not to test), loss aversion (perception of loss greater than gain), omission (focusing on harm of action more than of non-action), or confirmation (validating prior beliefs)] that can influence health decisions. Behavioral economics offers a roadmap for mitigating clinician biases using choice architecture and message framing, which involves changing the EHR environment to facilitate the desired (evidence-based) choice, and patient biases using priming, which uses direct communication strategies to address potential biases prior to clinical encounters. In Aim 1, we will develop patient- and clinician-directed nudges with input from key stakeholders. Feedback will also be used to develop and refine educational materials to support clinical testing. In Aim 2, we will pilot test the nudges using discrete choice experiments (DCE) to identify the optimal framing that best mitigate cognitive biases. Results of the pilot will be utilized to design a randomized clinical trial testing the nudge strategies.

OBJECTIVES:

To obtain input from clinician and patient stakeholders to design EHR based nudges that are acceptable and will increase the likelihood of ordering DPYD testing prior to prescribing a FP for GI cancer.

Aim 1: Develop and refine patient- and clinician- directed nudges that will address biases to DPYD testing. Hypothesis: Stakeholder feedback will result in acceptable and appropriate nudges.

Aim 1a. We will conduct focus groups with stakeholders and clinicians to refine the framing and content of EHR nudges that will best mitigate biases to ordering DPYD testing.

Aim 1b. We will conduct focus groups with patients to refine the framing of patient directed nudges that would prompt them to initiate discussion about DPYD testing with clinicians.

Aim 1c. Feedback from stakeholders will also be used to develop/refine clinician and patient educational websites.

Aim 2: Pilot test patient- and clinician- nudges using discrete choice experiments.

We will test the degree to each message is associated with the greatest intention to order testing (clinician), or prompt discussion regarding testing (patient) with in a sample of 35 clinicians and 75 patients.

The results of this pilot will be used as preliminary data for a NIH grant to conduct a prospective randomized, implementation trial to evaluate the effectiveness of the optimized nudges to enhance the adoption of DPYD testing as an evidence-based way to reduce TRAEs and improve the quality of care for cancer patients.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Fluent in English
  • Currently involved in the practice or policy of GI oncology/DPYD testing/FP use/Healthcare Development OR
  • Prescribed a FP for GI cancer diagnosis in the past six months AND Currently licensed to provide health care in Pennsylvania or New Jersey OR
  • Previous diagnosis of GI malignancy or family member who had GI malignancy

Exclusion Criteria:

  • Less than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Physician Focus Group
To develop patient- and clinician-directed nudges that will address biases to DPYD testing. Clinicians will be engaged to provide input on developing the content and design of the nudges that address biases that impact the decision to order DPYD testing. Feedback will be elicited for nudges based on relevancy, nudge timing, and appropriateness. We will also develop/refine patient- and clinician-focused educational materials and test results based on input from our focus groups.
Other: Focus Group
Open-ended group discussion of potential nudges to elicit constructive feedback on nudge development.
Other: Patient Focus Group
To develop patient-directed nudges that will address biases to DPYD testing. Patients will be engaged to provide input on developing the content and design of the nudges that address biases that impact the decision to order DPYD testing. Feedback will be elicited for nudge content, clarity, and perceived urgency. We will also develop/refine patient-focused educational materials and test results based on input from our focus groups.
Other: Focus Group
Open-ended group discussion of potential nudges to elicit constructive feedback on nudge development.
Experimental: Physician Discrete Choice
To pilot test clinician-nudges using discrete choice experiments, we will test the degree each nudge is associated with the perceived intention to order testing (clinician). Clinicians will be shown a series of nudges, and asked to choose which of each pair is the better nudge. The location/timing of the nudge in their workflow will be presented as part of the discrete choice.
Other: Discrete Choice
Survey involving choice between two potential nudges to elicit feedback on which nudge version is considered superior.
Experimental: Patient Discrete Choice
To pilot test patient-nudges using discrete choice experiments, we will test the degree each nudge is associated with perceived likelihood to prompt discussion regarding testing. Patients will be shown a series of nudges, and asked to choose which of each pair is the better nudge.
Other: Discrete Choice
Survey involving choice between two potential nudges to elicit feedback on which nudge version is considered superior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developmental Nudge Feedback
Time Frame: 90 minutes
Verbal data collected and coded
90 minutes
Discrete Nudge Feedback
Time Frame: 45 minutes
Binary choices
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sony Tuteja, PharmD, MS, Abramson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2024

Primary Completion (Actual)

April 25, 2025

Study Completion (Actual)

August 28, 2025

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 05224
  • P30CA016520 (U.S. NIH Grant/Contract)
  • 855903 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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