- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07532083
Implementing AI-Assisted, Patient-Friendly Imaging Report Summaries to Enhance Oncology Care Delivery
Study Overview
Status
Conditions
Detailed Description
Patient groups: Mixed-method approach to evaluate patient understanding of, and anxiety about, imaging results and communication experience regarding the results before and after implementation of AI-assisted, patient-friendly imaging report summaries that accompany the imaging results.
Provider group: Quasi-experimental staircase approach to sequentially roll out the tool to three provider cohorts. All hematology/oncology and gynecology oncology attending providers will be randomized by disease group into three relatively similar-sized cohorts based on group-level scan volumes, regardless of individual provider characteristics or communication style. Subsequent cohorts will be added every two months.
Surveys will be the main method of feedback collection at baseline and after implementation of the AI-assisted, patient-friendly imaging report summaries. Interviews will be conducted in a small subset of subjects.
Primary Objective:
- To evaluate patient comprehension of, and anxiety about, imaging results and communication experience regarding the results before and after implementation of AI-assisted, patient-friendly imaging report summaries that accompany the imaging results.
Secondary Objective(s):
- Patient Baseline Survey Objective: To evaluate comprehension of, and anxiety about, imaging results and communication experience regarding the results before the implementation of the AI-assisted, patient-friendly imaging report summaries that accompany the imaging results.
- Patient Summary Feedback Survey Objective: To evaluate comprehension of, and anxiety about, imaging results and communication experience regarding the results after the implementation of the AI-assisted, patient-friendly imaging report summaries that accompany the imaging results.
- Patient Interview Objectives: To understand the imaging result communication process from the patient's perspective.
- Provider Surveys Objective: The Baseline Survey will assess communication habits and preferences (frequency, method, timing), and perceived impact of the AI-Assisted, Patient-Friendly Imaging Report Summaries on clinical workload, and the Post-Implementation Surveys will evaluate changes in workload perception, satisfaction with the AI-Assisted, Patient-Friendly Imaging Report Summaries, the effectiveness of scan result communication with patients, and attitudes toward the use of AI-assisted material in patient care.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Supportive Oncology
- Phone Number: 608-263-6002
- Email: supportiveoncology@uwcarbone.wisc.edu
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Recruiting
- UW Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria (Patient Participants):
- Age 18 years or older
- Having a current or prior cancer diagnosis (any cancer type)
- Has active access to the UW Health MyChart patient portal.
- Receiving care at UW Health within the Division of Hematology, Medical Oncology and Palliative Care or Department of Gynecologic Oncology.
- Undergoing imaging studies (such as CT, MRI, or PET scans) as part of routine cancer care.
- Willing and able to complete electronic REDCap surveys.
- For interview participation: willing to participate in a 30-45-minute phone or video interview.
Inclusion Criteria (Provider Participants): Cancer care providers will be eligible to participate in this study if they meet all of the following criteria:
- Faculty physician (MD or DO) practicing in the Division of Hematology, Medical Oncology and Palliative Care or Department of Gynecologic Oncology at UW Health.
- Involved in reviewing, discussing, or sharing imaging results with patients.
- Planned to gain access to the AI-assisted, patient-friendly imaging summary tool as part of clinical implementation.
- Willing and able to complete electronic surveys or participate in a brief interview (~30 minutes).
Exclusion Criteria (Patients):
- Are unable to provide informed consent due to cognitive impairment or other limitations, as determined by the clinical or study team.
- Enrolled in an active interventional clinical trial. Patients on biospecimen, registry, or non-interventional studies are eligible.
- For the Patient Interview group only: Patients with radiographic disease progression will be excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Patient Participants
|
|
Provider Participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Patient Participants who report the information presented in their results is "Somewhat easy to understand" or "Very easy to understand" when reviewed by themselves
Time Frame: up to 15 minutes
|
Baseline data collected in a 10-15 minute survey from patient participants pre-implementation and in a 10-15 minute survey from patient participants post-implementation.
|
up to 15 minutes
|
|
Perceived impact of scan-result-related patient queries on Provider Participant workload
Time Frame: baseline, 3 months
|
Scored from 1 (no impact) to 5 (very frequently), higher scores indicate higher impact on workload.
Data collected at baseline (pre-implementation) and 3 months (post-implementation).
|
baseline, 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Patient Participants who report that reviewing scans increases their anxiety
Time Frame: up to 15 minutes
|
Baseline data collected in a 10-15 minute survey from patient participants pre-implementation and in a 10-15 minute survey from patient participants post-implementation.
|
up to 15 minutes
|
|
Proportion of Patient Participants who report that they were "somewhat" or "very" satisfied with how scan results were shared and explained
Time Frame: up to 15 minutes
|
Baseline data collected in a 10-15 minute survey from patient participants pre-implementation and in a 10-15 minute survey from patient participants post-implementation.
|
up to 15 minutes
|
|
Proportion of Patient Participants who report that they "almost always" or "often" contact their provider to ask questions regarding their scan results prior to their follow-up visit
Time Frame: up to 15 minutes
|
Baseline data collected in a 10-15 minute survey from patient participants pre-implementation and in a 10-15 minute survey from patient participants post-implementation.
|
up to 15 minutes
|
|
Provider Participant-reported frequency of scan-result-related patient queries
Time Frame: baseline, 3 months
|
Scored from 1 (never) to 5 (very frequently), higher scores indicate higher frequency.
Data collected at baseline (pre-implementation) and 3 months (post-implementation).
|
baseline, 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hamid Emamekhoo, MD, UW School of Medicine and Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-1716
- UW25122 (Other Identifier: OnCore ID)
- SMPH/DOM Hemato Med Onc (Other Identifier: UW Madison)
- Protocol Version 4/9/26 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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