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Recruiting Observational

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

NCT03407469 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2018-01-12
Last updated
2026-05-20

Condition(s) studied

Cancer-related Venous Thromboembolism

Investigational drug(s) / intervention(s)

Questionnaires

Questionnaires: Questionnaires completed at the time participant joins this study and then about 30 days, 3 months, 6 months, and 12 months after that. Questionnaires will be about quality of life and experiences with treatment for venous thromboembolism (VTE). It should take less than 10 minutes to complete the questionnaires each time.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adult (≥ 18 years) female or male subjects. 2. 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. 3. 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. 4. Intention for long-term treatment (at least 3 months) with anticoagulation. 5. Participants will be enrolled in the study within the first 5 days from initiation of anticoagulation. 6. Able to provide informed consent and complete study survey tools 7. Able to read and speak English. Exclusion Criteria: 1. Indication for anticoagulation other than cancer-related VTE. 2. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 4 at the time of study enrollment. 3. Life expectancy \< 3 months. 4. 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.

Primary outcome measure(s)

  • Self-Reported Adherence to Anticoagulation — Baseline up to 6 months
    Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale.

Trial sites (4)

FacilityCityRegionStatus
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Fundacion Valle del Lili Cali Colombia Recruiting
Hospital Clinic Barcelona Carrer de Villarroel, 170 Recruiting
Hospital German Trias i Pujol Barcelona Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03407469 on ClinicalTrials.gov ↗ ← All trials in Spain