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NCT Number: NCT05377320

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location contact

Yee Chung Chen, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Standard care

Other

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

Primary outcomes

  1. Medication use

    Time frame: Week 0

    The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.

  2. Medication use

    Time frame: Week 12

    The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.

  3. Medication use

    Time frame: Week 24

    The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.

  4. Imaging surveillance

    Time frame: Week 0

    The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.

  5. Imaging surveillance

    Time frame: Week 12

    The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.

  6. Imaging surveillance

    Time frame: Week 24

    The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.

Study contacts

Contact information is provided by the study sponsor or research team.

Yee Chung Cheng, MD

CONTACT

[email protected]

414-805-4600

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 17, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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