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

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Nudge Strategies for DPYD Testing in gastrointestinal cancer?

Research shows that using 'nudges' (gentle prompts) can improve communication between doctors and patients about serious illness, which can lead to better patient outcomes. While this isn't directly about DPYD testing, it suggests that nudges can be effective in healthcare settings to improve important conversations and decisions. ^{1 2 3 4 5}

Is the nudge strategy for gastrointestinal cancer safe for humans?

The research articles do not provide specific safety data for nudge strategies in gastrointestinal cancer, but they suggest that nudge interventions, which are behavioral prompts, are generally used to influence decision-making without direct physical effects, implying they are likely safe. ^{1 3 6 7 8}

How does the nudge strategy treatment for gastrointestinal cancer differ from other treatments?

The nudge strategy treatment for gastrointestinal cancer is unique because it uses behavioral nudges to encourage serious illness conversations between patients and clinicians, aiming to improve patient outcomes by aligning care with patient values and preferences. This approach is different from traditional treatments as it focuses on communication and decision-making rather than direct medical intervention. ^{1 6 8 9 10}

Research Team

Sony Tuteja, PharmD, MS

Principal Investigator

Abramson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Oncologist Perceptions of Algorithm-Based Nudges to Prompt Early Serious Illness Communication: A Qualitative Study. [2023]

3. United States 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Remote Patient-Reported Outcomes and Activity Monitoring to Improve Patient-Clinician Communication Regarding Symptoms and Functional Status: A Randomized Controlled Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Nudging within learning health systems: next generation decision support to improve cardiovascular care. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Hospital doctors' attitudes to brief educational messages that aim to modify diagnostic test requests: a qualitative study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Financial Incentives for Promoting Colorectal Cancer Screening: A Randomized, Comparative Effectiveness Trial. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of a nudge intervention providing simple feedback to clinicians of the consequence of radiation exposure on demand for computed tomography: a controlled study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Applying Behavioral Nudges in a Dietary Comparator for Surgical Trials: Developing the MediDiet. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of Behavioral Economic Incentives for Colorectal Cancer Screening in a Randomized Trial. [2022]