Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization

Recruiting now

Conditions studied: Cancer-related Venous Thromboembolism

In brief

The goal of this research study is to learn about the quality of life, experiences with treatment, and healthcare costs of patients who are receiving long-term treatment for venous thromboembolism (VTE) that is related to cancer. This is an investigational study. Up to 260 participants will be enrolled in this multicenter study. Up to 170 will take part in MD Anderson.

Key facts

Study ID

NCT03407469

Run by

M.D. Anderson Cancer Center

People needed

260

Starts

2018-01-12

Expected to finish

2026-12-31

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (≥ 18 years) female or male subjects.
• Confirmed symptomatic proximal or distal lower extremity deep venous thrombosis with or without pulmonary embolism or other venous thromboses. For a symptomatic lower extremity deep venous thrombosis confirmed by compression ultrasonography, venography, or specific computerized tomography (CT) venography, or a thrombus detected in the iliac veins on an abdominal or pelvic CT. For symptomatic pulmonary embolism confirmed by computerized tomographic pulmonary angiography, ventilation perfusion scan, or catheter pulmonary angiography.
• 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 for long-term treatment (at least 3 months) with anticoagulation.
• Participants will be enrolled in the study within the first 5 days from initiation of anticoagulation.
• Able to provide informed consent and complete study survey tools
• Able to read and speak English.

You may not qualify if…

• 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.
• Isolated pulmonary embolism, or isolated upper extremity deep venous thrombosis, or isolated splanchnic venous thrombosis, or isolated cerebral venous thrombosis confirmed by compression ultrasonography, venography, or CT.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Fundacion Valle del Lili — Cali, Colombia (enrolling)
• Hospital Clinic — Barcelona, Carrer de Villarroel, 170, Spain (enrolling)
• Hospital German Trias i Pujol — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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