Status:
RECRUITING
Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Cancer-related Venous Thromboembolism
Eligibility:
All Genders
18+ years
Brief 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 (VT...
Detailed Description
If you agree to take part in this study, you will complete 2 questionnaires either at an already-scheduled clinic visit or over the phone at the time you join this study and then about 30 days, 3 mont...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03407469
Start Date
January 12 2018
End Date
December 31 2026
Last Update
November 18 2025
Active Locations (4)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Fundacion Valle del Lili
Cali, Colombia
3
Hospital Clinic
Barcelona, Carrer de Villarroel, 170, Spain, 08036
4
Hospital German Trias i Pujol
Barcelona, Spain, 08916