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

NCT06559462 | Completed

• 1 other identifier: UPCC 05224
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

DPYD Gene Mutation; Gastrointestinal Cancer; Health Care Seeking Behavior

Keywords

Pharmacogenomic Testing; Pharmacogenetic Testing; Nudges; Implementation

Outcome Measures

Primary Outcomes (2)

• Developmental Nudge Feedback

  Verbal data collected and coded

  90 minutes

• Discrete Nudge Feedback

  Binary choices

  45 minutes

Study Arms (4)

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.

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.

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.

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.

Other: Discrete Choice

Interventions

Focus Group OTHER

Open-ended group discussion of potential nudges to elicit constructive feedback on nudge development.

Patient Focus Group; Physician Focus Group

Discrete Choice OTHER

Survey involving choice between two potential nudges to elicit feedback on which nudge version is considered superior.

Patient Discrete Choice; Physician Discrete Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Less than 18 years old

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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.

  PMID: 34996412 BACKGROUND

• Varughese 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.

  PMID: 35865463 BACKGROUND

• Hoffecker 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.

  PMID: 39669236 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Patient Acceptance of Health Care

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sony Tuteja, PharmD, MS

  Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients and providers will either participate in focus groups or complete a survey to provide feedback on developing nudges

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 19, 2024
• Study Start: September 19, 2024
• Primary Completion: April 25, 2025
• Study Completion: August 28, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)