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



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/25/2018
Start Date:January 12, 2018
End Date:December 2019
Contact:Cristhiam M. Rojas Hernandez, MD
Email:CR_Study_Registration@mdanderson.org
Phone:713-563-3070

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

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.

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 months, 6 months, and 12 months after that. These questionnaires will be
about your quality of life and experiences with treatment for VTE. It should take less than
10 minutes to complete the questionnaires each time.

Information from your medical record may also be collected at these time points.

Your participation will be over after the last questionnaires are completed at about 12
months after you enroll in the study.

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 72 hours 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.
We found this trial at
3
sites
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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170 Carrer de Villarroel
Barcelona, Carrer De Villarroel, 170 08036
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Barcelona,
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1660 Spring Hill Avenue
Mobile, Alabama 36604
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Mobile, AL
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