DPYD Gene MutationDPYD NudgesNCT06559462
Nudge Strategies for DPYD Testing in Patients With Gastrointestinal Cancers Treated With Fluoropyrimidines
A study testing Focus Group and Discrete Choice in people with DPYD Gene Mutation and Gastrointestinal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- DPYD Gene Mutation, Gastrointestinal Cancer, Health Care Seeking Behavior
- What is being tested?
- Focus Group and Discrete Choice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Focus Group, Discrete Choice
- Keywords
- Pharmacogenomic Testing, Pharmacogenetic Testing, Nudges, Implementation
- Medical subject headings
- Gastrointestinal Neoplasms, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
Open-ended group discussion of potential nudges to elicit constructive feedback on nudge development.
Discrete ChoiceOther
Survey involving choice between two potential nudges to elicit feedback on which nudge version is considered superior.
| Study group | Role | What they receive |
|---|---|---|
| Physician Focus Group | Other | 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. Receives: Other: Focus Group |
| Patient Focus Group | Other | 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. Receives: Other: Focus Group |
| Physician Discrete Choice | Experimental | 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. Receives: Other: Discrete Choice |
| Patient Discrete Choice | Experimental | 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. Receives: Other: Discrete Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Nudge Feedback
Verbal data collected and coded
Measured: 90 minutes
Discrete Nudge Feedback
Binary choices
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start19 Sep 2024
- Primary completion25 Apr 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DPYD Gene MutationStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients and providers will either participate in focus groups or complete a survey to provide feedback on developing nudges
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sony Tuteja, PharmD, MS, Principal investigator, Abramson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559462
- Sponsor's protocol ID
- UPCC 05224
- Acronym
- DPYD Nudges
- Status last verified
- Nov 2025
- First submitted
- 25 Jul 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lau-Min KS, Varughese LA, Nelson MN, Cambareri C, Reddy NJ, Oyer RA, Teitelbaum UR, Tuteja S. Preemptive pharmacogenetic testing to guide chemotherapy dosing in patients with gastrointestinal malignancies: a qualitative study of barriers to implementation. BMC Cancer. 2022 Jan 8;22(1):47. doi: 10.1186/s12885-022-09171-6.
PubMed 34996412Varughese LA, Bhupathiraju M, Hoffecker G, Terek S, Harr M, Hakonarson H, Cambareri C, Marini J, Landgraf J, Chen J, Kanter G, Lau-Min KS, Massa RC, Damjanov N, Reddy NJ, Oyer RA, Teitelbaum UR, Tuteja S. Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI): Study Protocol for a Pragmatic Implementation Trial for Establishing DPYD and UGT1A1 Screening to Guide Chemotherapy Dosing. Front Oncol. 2022 Jul 5;12:859846. doi: 10.3389/fonc.2022.859846. eCollection 2022.
PubMed 35865463Hoffecker G, Varughese LA, Bleznuck J, Landgraf J, Wollack C, Chen J, Ritchie MD, Nathanson KL, Tuteja S. Customizing the electronic health record for delivery of pharmacogenetics. Genet Med Open. 2023 Mar 8;1(1):100779. doi: 10.1016/j.gimo.2023.100779. eCollection 2023. No abstract available.
PubMed 39669236
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Nudge Strategies to Increase the Adoption of DPYD Testing in Patients With Gastrointestinal (GI) Malignancies Treated With Fluoropyrimidines.
- ClinicalTrials.gov ID
- NCT06559462
- Acronym / sponsor ID
- DPYD Nudges / UPCC 05224
- Keywords
- Pharmacogenomic Testing, Pharmacogenetic Testing, Nudges, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients and providers will either participate in focus groups or complete a survey to provide feedback on developing nudges
| Arm | Type | Receives |
|---|---|---|
| Physician Focus Group | Other | Other: Focus GroupTo 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. |
| Patient Focus Group | Other | Other: Focus GroupTo 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. |
| Physician Discrete Choice | Experimental | Other: Discrete ChoiceTo 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. |
| Patient Discrete Choice | Experimental | Other: Discrete ChoiceTo 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupOpen-ended group discussion of potential nudges to elicit constructive feedback on nudge development. | Other | Patient Focus Group, Physician Focus Group |
| Discrete ChoiceSurvey involving choice between two potential nudges to elicit feedback on which nudge version is considered superior. | Other | Patient Discrete Choice, Physician Discrete Choice |
Primary outcome
Developmental Nudge Feedback
Time frame: 90 minutes
Verbal data collected and coded
Discrete Nudge Feedback
Time frame: 45 minutes
Binary choices
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 34996412Lau-Min KS, Varughese LA, Nelson MN, Cambareri C, Reddy NJ, Oyer RA, Teitelbaum UR, Tuteja S. Preemptive pharmacogenetic testing to guide chemotherapy dosing in patients with gastrointestinal malignancies: a qualitative study of barriers to implementation. BMC Cancer. 2022 Jan 8;22(1):47. doi: 10.1186/s12885-022-09171-6.
- Background: PubMed 35865463Varughese LA, Bhupathiraju M, Hoffecker G, Terek S, Harr M, Hakonarson H, Cambareri C, Marini J, Landgraf J, Chen J, Kanter G, Lau-Min KS, Massa RC, Damjanov N, Reddy NJ, Oyer RA, Teitelbaum UR, Tuteja S. Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI): Study Protocol for a Pragmatic Implementation Trial for Establishing DPYD and UGT1A1 Screening to Guide Chemotherapy Dosing. Front Oncol. 2022 Jul 5;12:859846. doi: 10.3389/fonc.2022.859846. eCollection 2022.
- Background: PubMed 39669236Hoffecker G, Varughese LA, Bleznuck J, Landgraf J, Wollack C, Chen J, Ritchie MD, Nathanson KL, Tuteja S. Customizing the electronic health record for delivery of pharmacogenetics. Genet Med Open. 2023 Mar 8;1(1):100779. doi: 10.1016/j.gimo.2023.100779. eCollection 2023. No abstract available.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sony Tuteja, PharmD, MS principal investigator
Abramson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus Group and Discrete Choice in people with DPYD Gene Mutation and Gastrointestinal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Nudge Feedback (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06559462, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.