PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemia; Coronary Artery Disease; Heart Failure; Hypertension; Diabetes Mellitus; Cardiomyopathies; Peripheral Artery Disease; Cardiotoxicity
• Intervention / Treatment: Other: Clinical Decision Aid; Other: Standard Care

Detailed Description

For this feasibility study, the researchers will create the clinical decision aid and test the central hypothesis that this novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists and will favorably impact appropriate medication use and cardiac imaging surveillance. The hypothesis is supported by preliminary data suggesting that an initial and rudimentary version of the clinical aid increases appropriate medication use and imaging follow-up in cardio-oncology patients. Success will be determined by ≥85% of clinic visits using the clinical decision aid resulting in pursuit of medication use and cardiac imaging surveillance patterns commensurate with recommendations specific to cancer survivors, with overall rates the same or higher than the group without the clinical decision aid, as well as overall favorable patient and physician focus group comments and survey responses.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Yee Chung Cheng, MD; Phone Number: 414-805-4600; Email: ycheng@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert & the Medical College of Wisconsin
      • Principal Investigator: Yee Chung Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Cancer survivors at intermediate, high, or very high risk for developing cardiovascular disease will pursue a cardio-oncology visit.

Description

Inclusion Criteria:

1. Patients ≥18 years with a history of cancer.
2. Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis.
3. Clinically at intermediate, high, or very high risk for cardiovascular diseases determined based on imprecise clinical risk models, such as those used for cardiac dysfunction.
4. Ability to understand a written informed consent form, and willing to sign it prior to study registration.

Exclusion Criteria:

1. Patient <18 years.
2. Without a personal history of cancer.
3. Existing cardiomyopathy diagnosed after cancer diagnosis.
4. Documented cognitive impairment.
5. Patient or patient representative who is unable and unwilling to sign the informed consent form.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clinical Decision Aid Group; In this group, physicians will use standard care plus the clinical decision aid.	Other: Clinical Decision Aid; The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24.
Control Group; In this group, physicians will use standard care only.	Other: Standard Care; Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication use	The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.	Week 0
Medication use	The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.	Week 12
Medication use	The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.	Week 24
Imaging surveillance	The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.	Week 0
Imaging surveillance	The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.	Week 12
Imaging surveillance	The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.	Week 24

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Yee Chung Cheng, MD, Medical College of Wisconsin

Publications and helpful links

General Publications

• Brown SA, Chung BY, Doshi K, Hamid A, Pederson E, Maddula R, Hanna A, Choudhuri I, Sparapani R, Bagheri Mohamadi Pour M, Zhang J, Kothari AN, Collier P, Caraballo P, Noseworthy P, Arruda-Olson A; Cardio-Oncology Artificial Intelligence Informatics and Precision Equity (CAIPE) Research Team Investigators. Patient similarity and other artificial intelligence machine learning algorithms in clinical decision aid for shared decision-making in the Prevention of Cardiovascular Toxicity (PACT): a feasibility trial design. Cardiooncology. 2023 Jan 23;9(1):7. doi: 10.1186/s40959-022-00151-0.
• Brown SA, Hamid A, Pederson E, Bs AH, Maddula R, Goodman R, Lamberg M, Caraballo P, Noseworthy P, Lukan O, Echefu G, Berman G, Choudhuri I; Cardio-Oncology Artificial Intelligence Informatics & Precision Equity (CAIPE) and Patient Similarity Algorithms in the Prevention of Cardiovascular Toxicity (PACT) Research Team Investigators. Simplified rules-based tool to facilitate the application of up-to-date management recommendations in cardio-oncology. Cardiooncology. 2023 Oct 27;9(1):37. doi: 10.1186/s40959-023-00179-w.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: machine learning; cancer; artificial intelligence; adverse events; clinical decision aid; cardiac dysfunction; cardio-oncology
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Heart Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Neoplasms; Heart Failure; Hypertension; Ischemia; Diabetes Mellitus; Cardiomyopathies; Peripheral Arterial Disease; Coronary Artery Disease; Cardiotoxicity; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: PRO00039290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No