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NCT05377320 | NOT YET RECRUITING | Heart Failure

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

Medical College of Wisconsin

Information provided by (Responsible Party):

Yee Chung Cheng

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.

Condition or disease

Heart Failure

Coronary Artery Disease

Peripheral Artery Disease

Ischemia

Hypertension

Diabetes Mellitus

Cardiomyopathies

Cardiotoxicity

Intervention/treatment

Clinical Decision Aid

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
Estimated Enrollment : 60 participants
Official Title : PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Criteria
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.
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

Location Details

NCT05377320

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Wisconsin

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226