Clinical trial NCT06985953: Evaluating the Communication Between Patients and Providers in Cancer Clinics
Official title: Evaluating the Impact of TrialTalkTM; to Foster Equitable Cancer Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: communication
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria - 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
* potentially eligible for a therapeutic phase I, II or III clinical trial
* can read and understand English to complete the study questionnaires
* had previous visits with the enrolled provider

Exclusion Criteria - Patients:

* previous enrollment in cancer intervention clinical trial
* have moderate to severe cognitive impairment

Primary outcomes:
measure: Fidelity - Providers
timeFrame: Monthly for 6 months
measure: Sustainability of TrialTalk™ communication tool
timeFrame: 1 year
measure: Change in quality of communication
timeFrame: Up to 2 hours
measure: Change in trust of provider
timeFrame: Up to 2 hours
measure: Usefulness of tool
timeFrame: Up to 2 hours
measure: Understanding of treatment options
timeFrame: Up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Monica Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: