Measurement of Adherence and Health-related Quality of Life, and Health-Care Resource Utilization During Anticoagulation Therapy in Cancer-Related Venous Thromboembolism (VTE)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Colombia
Fundacion Valle del Lili
RECRUITING
Cali
Spain
Hospital Clinic
RECRUITING
Barcelona
Hospital German Trias i Pujol
RECRUITING
Barcelona
Contact Information
Primary
Cristhiam M. Rojas Hernandez, MD
cmrojas@mdanderson.org
713-563-3070
Time Frame
Start Date: 2018-01-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 260
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov