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Treatment Adherence, Quality of Life, and Resource Utilization during Anticoagulant Therapy for Cancer-Related VTE

Cristhiam Rojas Hernandez, a member of the Hemostasis Study Group, is the principal investigator of a clinical research project titled “Measurement of Adherence and Health-related Quality of Life, and Health-care Resource Utilization during Anticoagulation Therapy in Cancer-related Venous Thromboembolism.”

Cancer-related venous thromboembolism (VTE) is a prevalent problem that occurs in 20%-25% of patients with a malignancy. It causes significant morbidity and it is one of the most important causes of mortality in cancer (Khorana AA et al., 2007, Yu YB et al., 2012). The current standard of care for treatment of cancer-related VTE is parenteral anticoagulation for at least several months (Lee AY and Peterson EA., 2013; Lyman GH, Khorana AA, et al., 2013, Farge D, Bounameaux H et al., 2016).

There are no extensive data on the treatment adherence, acceptability and health-related quality of life (HRQL) in patients with cancer who require long-term anticoagulation therapy. In qualitative studies, patients have reported acceptance of parenteral long-term anticoagulation for VTE treatment despite a variety of symptoms related to VTE and anticoagulation treatment, some of them described as distressing (Noble SI and Finlay IG, 2005; Seaman S, Nelson A, Noble S, 2014).

The objectives of the study are to assess self-reported adherence and the HRQL change at different long-term time points during anticoagulation treatment of cancer-related VTE associated with different anticoagulation strategies. The approach is innovative, since it will provide information regarding two important aspects of long term anticoagulation:

  1. Clinical practice evaluation of the impact of long-term anticoagulation in cancer-related VTE on HRQL.
  2. A prospective and long-term evaluation of adherence to anticoagulation in cancer, where current available data are limited to cross-sectional studies.

Eligibility Criteria

  • Adult (≥ 18 years), female or male.
  • Confirmed symptomatic or incidental VTE.
  • Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 2 years prior to VTE. The diagnosis of cancer must be objectively documented by histopathologic diagnosis.
  • Intention of long-term treatment (at least 3 months) with anticoagulation.

Participants will be enrolled in the study within the first 72 hours after initiation of anticoagulation. They must be able to provide informed consent and complete study survey tools.

Exclusion Criteria

  • Indication for anticoagulation other than cancer-related VTE.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of 4 at the time of study enrollment.
  • Life expectancy < 3 months.

Cris Rojas Hernandez is Assistant Professor of Pulmonary Medicine at the MD Anderson Cancer Center in Houston, Texas. For more information about the study, please contact him at [email protected].