What this study is
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.
What's being tested
- Questionnaires
Intervention · BEHAVIORAL
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 details
- Official title
- Measurement of Adherence and Health-related Quality of Life, and Health-Care Resource Utilization During Anticoagulation Therapy in Cancer-Related Venous Thromboembolism (VTE)
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Cancer-related Venous Thromboembolism
- Enrolling
- 260 people
- Starts
- 2018-01-12
- Est. completion
- 2026-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
- Cristhiam M Rojas Hernandez, MD · Contactcmrojas@mdanderson.org
Recruiting
3 sites outside the US
- Recruiting
Hospital Clinic
Barcelona, Carrer de Villarroel, 170, Spain
- Carme Font, MD · Contact
RecruitingHospital German Trias i Pujol
Barcelona, Spain
- : Juan J Lopez Nuñez, MD · Contact
- Contactjjlopez.germanstrias@gencat.cat
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2017-0303
Principal investigator
Cristhiam M. Rojas Hernandez, MD
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.