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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient <18 years.

Without a personal history of cancer.

Existing cardiomyopathy diagnosed after cancer diagnosis.

Documented cognitive impairment.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinical Decision Aid

    Other intervention

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

  • Standard Care

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Clinical Decision Aid Group1 intervention
Group B: Control Group1 intervention

Trial outcomes

Primary outcomes

1

Medication use

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

Time frame
Week 0
2

Medication use

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

Time frame
Week 12
3

Medication use

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

Time frame
Week 24
4

Imaging surveillance

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

Time frame
Week 0

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: