跳至主要内容
临床试验/NCT06985953
NCT06985953招募中不适用

Evaluating the Impact of TrialTalkTM; to Foster Equitable Cancer Care

University of Wisconsin, Madison3 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2025年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
135
试验地点
3
主要终点
Fidelity - Providers

研究概览

简要总结

This clinical trial seeks to understand patients' experiences with the healthcare team and the quality of communication between patients and doctors in cancer clinics. The main question it aims to answer is:

  • Does TrialTalk™ improve communication between providers and patients?

Participants will complete questionnaires before and after their standard of care clinic visit.

详细描述

The online TrialTalk™ training system uses evidence-based principles and best practices for instructional design for adult learners. The system uses a four-stage learning goal framework (i.e., knowledge, skill, understanding, and application) to ensure that the training moves from rote knowledge- and skill acquisition to integration, application, ownership, and long-term memory in clinical practice. The first module introduces the TrialTalk™ framework, why it's relevant and effective to patients and providers and describes the learning goals for the rest of the course. The second module focuses on essential elements of the TrialTalk™ conversation process through examples, metaphors, and description, followed by exercises at the end of the module that solidify the basic concepts of the conversational process. The third module focuses on the essential components of the diagram, how it integrates with the conversational process, and how to use it in a patient meeting. A set of assessment and reflection questions at the end of module 3 reinforces the concepts and components of the diagram. The fourth module brings all the TrialTalk™ elements together through case studies that exemplify how the conversational process and diagram work together in different types of patient meetings (for example, a new patient versus an established patient). Assessment and reflection questions at the end of module 4 focus on integrating and using the TrialTalk™ method in practice. Learners also develop a three-day action plan to begin to use TrialTalk™ with their patients. The TrialTalk™ training system provides learning resources to physicians such as a self-assessment rubric, FAQs, a checklist, and diagram template.

TrialTalk™ intervention includes two components: provider-focused skills-based training to ensure providers' competency in using the conversational and diagrammatic aspects of TrialTalk™, and the patient-facing component, which is the TrialTalk™ tool itself, to help patients understand their prognosis and treatment options in order to make a shared informed decision about their cancer management.

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
否

入选标准

  • •Providers:
  • •Hematologists, medical oncologists, or hematology/oncology fellows
  • •Willing to complete TrialTalk™ training
  • •Inclusion Criteria - Patients:
  • •≥ 18 years old
  • •have a confirmed diagnosis of cancer
  • •identify as Black, African American, or non-Hispanic White
  • •can read and understand English to complete the study questionnaires
  • •had previous visits with the enrolled provider

排除标准

  • •Providers:
  • •providers who received previous training in the TrialTalk™ method or used it in practice before will be excluded
  • •Exclusion Criteria - Patients:
  • •- have moderate to severe cognitive impairment as determined by participant's provider

研究组 & 干预措施

Provider participants

Experimental

Cancer providers who have received TrialTalk™ training.

干预措施: TrialTalk™ (Other)

Patient participants

Experimental

Patients who are treated by a cancer provider who has received TrialTalk™ training.

干预措施: TrialTalk™ (Other)

结局指标

主要结局

Fidelity - Providers

时间窗: Monthly for 6 months

Fidelity to the tool by providers is measured by a 9 item qualitative questionnaire, asking how many times and how providers used TrialTalk™ when talking with their patients.

Sustainability of TrialTalk™ communication tool

时间窗: 1 year

Providers will answer a 3 item questionnaire regarding their use of TrialTalk™. Items are scored on a 5 point Likert scale, where 1 = not at all and 5 = very much. Higher scores indicate better sustainability of the tool.

Change in quality of communication

时间窗: Up to 2 hours

Patient participants will rate the quality of communication they receive from their provider. They will answer a 13 item questionnaire with a 6-point Likert scale, where 0= not done and 5 = excellent. Scores range from 0-65, with higher scores indicating better communication.

Change in trust of provider

时间窗: Up to 2 hours

Patient participants will rate how much they trust their provider using a 6 item questionnaire. Scores are on a 5-point Likert scale, where 1 = not at all and 5 = extremely. Scores range from 6-30, with higher scores indicating greater trust.

Usefulness of tool

时间窗: Up to 2 hours

Patient participants will complete a 7 item questionnaire about the visual diagram created with their provider. It is scored on a 5-point Likert scale, where 1 = not at all and 5 = extremely. Scores range from 7-35, with higher scores indicating greater usefulness.

Understanding of treatment options

时间窗: Up to 2 hours

Patient participants will answer 9 yes or no questions regarding how well they understood the options presented to them during the visit.

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 (3)

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