跳至主要内容
临床试验/NCT06559462
NCT06559462已完成不适用

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

Abramson Cancer Center at Penn Medicine2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Developmental Nudge Feedback

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Less than 18 years old

结局指标

主要结局

Developmental Nudge Feedback

时间窗: 90 minutes

Verbal data collected and coded

Discrete Nudge Feedback

时间窗: 45 minutes

Binary choices

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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