Clinical Trial 23949

• Overview

  Study Title:

  A Mixed Methods Study Examining Patient Reported Outcomes and Health-Related Quality of Life Among Breast Cancer Survivors with Cardiotoxicity

  Objective:

  To examine the differences between breast cancer survivors with (n=32) and without cardiotoxicity (n=32) on fatigue, anxiety, perceived cognitive impairment, and health-related quality of life considering risk factors for more severe cardiotoxicity age, cancer treatment history, obesity, smoking status, menopausal status, comorbidities, and physical inactivity as covariates.

• Inclusion Criteria

  Key Inclusion Criteria:
  • 18 years of age or older.
  • Have a previous diagnosis of stage I-III BC.
  • Currently referred to cardio-oncology care for cardiovascular complications and/or development of CVD likely due to BC treatment, diagnosed in accordance with the 2022 European Society of Cardiology Cardio-Oncology Guidelines (e.g. decrease of 10% or more left ventricular ejection fraction (LVEF) or LVEF > Have completed systemic therapy, such as radiation, chemotherapy, or molecular targeted therapy (with the exception of maintenance hormone therapy)
  • Are able to speak and read English. Matched control participants (BCS without cardiotoxicity) must meet the outlined criteria except for eligibility criteria number 3: (i.e., currently diagnosed with cardiotoxicity).

• Exclusion Criteria

  Key Exclusion Criteria:
  • Have had a recurrence of their BC diagnosis or a history of other primary cancers.
  • Have a diagnosed or self-reported neurological condition that would interfere with study participation (e.g. stroke within the last 5 years).
  • Pregnant.
  • Receiving end of life care at the time of consent completion.
  • Male.

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