Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires.
- Who it may be relevant to
- Registry conditions: Cancer-related Venous Thromboembolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Colombia, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
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 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.
Interventions
- Behavioral 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). It should take less than 10 minutes to complete the questionnaires each time.
Primary outcome measures
- Self-Reported Adherence to Anticoagulation [Time frame: Baseline up to 6 months]
Secondary outcome measures (1)
- HRQL Variables in Patients for Cancer-Related VTE Treated with Anticoagulation [Time frame: Baseline, 3 months, and 6 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Hospital Clinic — Barcelona
- Hospital German Trias i Pujol — Barcelona
United States · 1 center
- University of Texas MD Anderson Cancer Center — Houston
Colombia · 1 center
- Fundacion Valle del Lili — Cali
Identifiers
NCT: NCT03407469 · 2017-0303 · NCI-2018-00900