Nudge Strategies for Gastrointestinal Cancer

(DPYD Nudges Trial)

Overseen By Sony Tuteja, PharmD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 35

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how patients receive information about DPYD testing before starting chemotherapy for gastrointestinal cancer. DPYD testing identifies individuals at risk for severe side effects from common chemotherapy drugs like 5-fluorouracil and capecitabine. Participants will help create and evaluate messages that encourage discussions with healthcare providers about testing. This trial may suit those diagnosed with GI cancer or with a family history of it and who are fluent in English. As an unphased trial, this study offers a unique opportunity to enhance patient education and safety in chemotherapy treatment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these nudge strategies for DPYD testing are safe?

Research has shown that DPYD testing can predict who might experience severe side effects from chemotherapy drugs like 5-fluorouracil and capecitabine. These drugs can cause nausea, diarrhea, and blood problems. Changes in the DPYD gene can worsen these side effects and, in rare cases, make them life-threatening.

Studies have found that conducting DPYD testing before starting these drugs can reduce the risk of serious side effects. It helps doctors determine who might need closer monitoring or a dosage adjustment. While the treatment can have serious side effects, DPYD testing serves as a tool to make it safer for those who need it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative nudge strategies to improve DPYD testing for gastrointestinal cancer patients. Unlike traditional approaches, these nudges aim to address biases and enhance decision-making for both patients and clinicians. By incorporating feedback from focus groups and using discrete choice experiments, the trial seeks to refine educational materials and better integrate testing into clinical workflows. This could lead to more personalized and effective care, addressing gaps in current testing protocols.

What evidence suggests that this trial's nudge strategies for DPYD testing could be effective for gastrointestinal cancer patients?

This trial will explore nudge strategies to encourage DPYD testing, which studies have shown can reduce harmful side effects from chemotherapy drugs like 5-fluorouracil and capecitabine. By identifying gene changes, doctors can pinpoint patients at risk for severe side effects. Research indicates that using this test leads to fewer serious problems for patients with gastrointestinal cancers, reducing the likelihood of nausea, diarrhea, or blood issues caused by chemotherapy. Overall, DPYD testing enhances the safety of chemotherapy for at-risk patients. ^{2 3 5 6 7}

Who Is on the Research Team?

Sony Tuteja, PharmD, MS

Principal Investigator

Abramson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with gastrointestinal cancers who are going to be treated with chemotherapy drugs like 5-FU or capecitabine. It aims to include those interested in participating in discussions on how best to communicate the importance of DPYD genetic testing, which can predict severe side effects from these drugs.

Inclusion Criteria

Fluent in English

I was prescribed a FP for GI cancer and am licensed to provide care in PA or NJ.

Currently involved in the practice or policy of GI oncology/DPYD testing/FP use/Healthcare Development

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development of Nudges

Focus groups with stakeholders and clinicians to refine the framing and content of EHR nudges

4 weeks

Multiple focus group sessions

Pilot Testing of Nudges

Pilot test patient- and clinician-nudges using discrete choice experiments

4 weeks

Discrete choice experiments with 35 clinicians and 75 patients

Follow-up

Participants are monitored for feedback on the effectiveness of nudges

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nudge Strategies for DPYD Testing

Trial Overview The study is not testing a drug but rather different strategies for encouraging DPYD gene testing before starting chemotherapy. Participants will either join focus groups or evaluate messages designed to inform about the benefits of this genetic test.

How Is the Trial Designed?

Group I: Physician Focus Group Experimental Treatment 1 Intervention

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.

Group II: Physician Discrete Choice Experimental Treatment 1 Intervention

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.

Group III: Patient Focus Group Experimental Treatment 1 Intervention

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.

Group IV: Patient Discrete Choice Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A qualitative study involving 25 oncology clinicians revealed that algorithm-based nudges effectively promote early serious illness conversations (SICs), which are crucial for improving patient mood and end-of-life care quality.

Clinicians noted that while these nudges helped with documentation and peer comparisons, challenges such as cancer-specific differences and the nature of communication methods need to be addressed to enhance the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologist Perceptions of Algorithm-Based Nudges to Prompt Early Serious Illness Communication: A Qualitative Study. Parikh, RB., Manz, CR., Nelson, MN., et al.[2023]

In a pilot study with 213 primary care patients, providing quantitative information about colorectal cancer screening significantly increased the likelihood of patients getting screened compared to those who did not receive this information.

While a nudge towards stool testing (FIT) increased perceived risk of colorectal cancer, it did not lead to a higher screening uptake, suggesting that simply nudging patients may not be as effective as providing clear quantitative data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial. Schwartz, PH., Perkins, SM., Schmidt, KK., et al.[2018]

This study will evaluate the effectiveness of both clinician- and patient-directed nudges to increase the completion of serious illness conversations (SICs) among high-risk cancer patients, involving 166 clinicians and approximately 5500 patients.

The primary outcome will be the time to SIC documentation, with secondary outcomes including palliative care referrals and the use of aggressive end-of-life care, aiming to improve patient outcomes and promote health equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial. Takvorian, SU., Bekelman, J., Beidas, RS., et al.[2022]

The use of nudge theory in clinical decision support systems (CDSS) could help bridge the gap between existing healthcare evidence and actual clinical practice, potentially improving patient outcomes.

Integrating nudges with electronic health records and artificial intelligence may enhance clinician adherence to guidelines, especially in areas lacking robust evidence, by standardizing behavior in uncertain clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging within learning health systems: next generation decision support to improve cardiovascular care. Chen, Y., Harris, S., Rogers, Y., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06559462/nudge-strategies-for-dpyd-testing-in-patients-with-gastrointestinal-cancers-treated-with-fluoropyrimidines

Nudge Strategies for DPYD Testing in Patients With ... Nudge Strategies for DPYD Testing in Patients With Gastrointestinal Cancers Treated With Fluoropyrimidines. Last updated: June 22, 2025.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352563/

Implementation of DPYD and UGT1A1 Testing in Patients With ... To determine the feasibility and effectiveness of implementing pretreatment DPYD/UGT1A1 testing in patients with gastrointestinal cancer and its ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.02364

DPYD Testing: Time to Put Patient Safety First This commentary will establish that pretreatment DPYD testing is well justified and recommend dose reduction in those patients with a decreased function ...

4. gioncologynow.com gioncologynow.com/post/pretreatment-dpyd-ugt1a1-testing-reduces-adverse-outcomes-in-patients-with-gi-cancer

Pretreatment DPYD/UGT1A1 Testing Reduces Adverse ... A recent study has incorporated pretreatment DPYD/UGT1A1 testing in patients with gastrointestinal cancers to analyze the practice's feasibility ...

5. oncologynurseadvisor.com oncologynurseadvisor.com/news/dpyd-ugt1a1-testing-traes-gastrointestinal-cancer/

DPYD/UGT1A1 Testing May Decrease Risk of TRAEs in ... DPYD/UGT1A1 testing before treatment with a fluoropyrimidine or irinotecan can reduce the risk of serious treatment-related adverse events ...

6. withpower.com withpower.com/trial/phase-dpyd-gene-mutation-7-2024-c10ba

Nudge Strategies for Gastrointestinal Cancer (DPYD ... 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11995504/

Evaluating digital nudge interventions for the promotion of ... This study aims to synthesize the effects of digital nudge interventions on promoting cancer screening behaviors in high-risk individuals.