CancerNCT06985953
Evaluating the Communication Between Patients and Providers in Cancer Clinics
A study testing TrialTalk™ in people with Cancer, run by University of Wisconsin, Madison at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- TrialTalk™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Dec 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hematologists, medical oncologists, or hematology/oncology fellows
- Willing to complete TrialTalk™ training
- ≥ 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
Who cannot join
- providers who received previous training in the TrialTalk™ method or used it in practice before will be excluded
- have moderate to severe cognitive impairment as determined by participant's provider
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Alana Rojewski, PhD, 843-876-1593, rojewski@musc.edu
- Not yet recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Divya Gupta, MD, 312-695-0990, divya.gupta@northwestern.edu
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Cancer Connect, 800-622-8922, clinicaltrials@cancer.wisc.edu
Monica Patel, MD
About this study
Official title: Evaluating the Impact of TrialTalkTM; to Foster Equitable Cancer Care
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- TrialTalk™
- Keywords
- communication
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrialTalk™Other
TrialTalk™ is a communication tool that focuses on making the options visible and accessible while involving patients in the discussion.
| Study group | Role | What they receive |
|---|---|---|
| Provider participants | Experimental | Cancer providers who have received TrialTalk™ training. Receives: Other: TrialTalk™ |
| Patient participants | Experimental | Patients who are treated by a cancer provider who has received TrialTalk™ training. Receives: Other: TrialTalk™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity - Providers
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.
Measured: Monthly for 6 months
Sustainability of TrialTalk™ communication tool
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.
Measured: 1 year
Change in quality of communication
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.
Measured: Up to 2 hours
Change in trust of provider
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.
Measured: Up to 2 hours
Usefulness of tool
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.
Measured: Up to 2 hours
Understanding of treatment options
Patient participants will answer 9 yes or no questions regarding how well they understood the options presented to them during the visit.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start18 Dec 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Clinical Trials in Oncology
- Responsible party
- Sponsor
- Investigators
- Monica Patel, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985953
- Sponsor's protocol ID
- 2025-0274
- Other IDs
- A534260, SMPH/MEDICINE/HEM-ONC, UW24152
- Status last verified
- Sep 2026
- First submitted
- 14 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of TrialTalkTM; to Foster Equitable Cancer Care
- ClinicalTrials.gov ID
- NCT06985953
- Acronym / sponsor ID
- 2025-0274
- Conditions
- Cancer
- Keywords
- communication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Alliance for Clinical Trials in Oncology
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider participants | Experimental | Other: TrialTalk™Cancer providers who have received TrialTalk™ training. |
| Patient participants | Experimental | Other: TrialTalk™Patients who are treated by a cancer provider who has received TrialTalk™ training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hematologists, medical oncologists, or hematology/oncology fellows
- Willing to complete TrialTalk™ training
- ≥ 18 years old
- have a confirmed diagnosis of cancer
- identify as Black, African American, or non-Hispanic White
Key exclusion criteria (2 listed)
- providers who received previous training in the TrialTalk™ method or used it in practice before will be excluded
- have moderate to severe cognitive impairment as determined by participant's provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrialTalk™TrialTalk™ is a communication tool that focuses on making the options visible and accessible while involving patients in the discussion. | Other | Patient participants, Provider participants |
Primary outcome
Fidelity - Providers
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monica Patel, MD principal investigator
University of Wisconsin, Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrialTalk™ in people with Cancer, run by University of Wisconsin, Madison at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity - Providers (time frame: Monthly for 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.