Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
Recruiting
Observational Study
Cancer-related Venous Thromboembolism
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
260 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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 ultr…
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.
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