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

NCT05377320 | Not Yet Recruiting DMC

• 1 other identifier: PRO00039290
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Coronary Artery Disease; Peripheral Artery Disease; Ischemia; Hypertension; Diabetes Mellitus; Cardiomyopathies; Cardiotoxicity

Keywords

clinical decision aid; cancer; cardiac dysfunction; cardio-oncology; artificial intelligence; machine learning; adverse events

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Clinical Decision Aid Group

In this group, physicians will use standard care plus the clinical decision aid.

Other: Clinical Decision Aid

Control Group

In this group, physicians will use standard care only.

Other: Standard Care

Interventions

Clinical Decision Aid OTHER

The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24.

Clinical Decision Aid Group

Standard Care OTHER

Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients ≥18 years with a history of cancer.
• Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis.
• 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.
• Ability to understand a written informed consent form, and willing to sign it prior to study registration.

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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.

  PMID: 36691060 BACKGROUND

• Brown SA, Fang MZ, Sparapani R, Zhou Y, Osinski K, Taylor B, Yu D, Blessing J, Shah R, Collier P, BagheriMohamadiPour M, Zhang J, Kothari A, Echefu G, Rickards J, Otto C, Sanchez Z, Olson J, Arruda-Olson A, Cheng YC, Cheng F; Cardio-Oncology Artificial Intelligence Informatics and Precision Equity, and Patient Similarity Algorithms in the Prevention of Cardiovascular Toxicity Research Team Investigators. PrevCardioOncAI: Machine Learning Algorithms for Predicting Cardiovascular Disease in Cancer Survivors. J Am Heart Assoc. 2025 Dec 16;14(24):e030363. doi: 10.1161/JAHA.123.030363. Epub 2025 Dec 11.

  PMID: 41378455 DERIVED

• 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.

  PMID: 37891699 DERIVED

MeSH Terms

Conditions

Heart Failure; Coronary Artery Disease; Peripheral Arterial Disease; Ischemia; Hypertension; Diabetes Mellitus; Cardiomyopathies; Cardiotoxicity; Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yee Chung Cheng, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yee Chung Cheng, MD

CONTACT

414-805-4600; ycheng@mcw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 17, 2022
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)