Clinical trial · Observational
Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
Measurement of Adherence and Health-related Quality of Life, and Health-Care Resource Utilization During Anticoagulation Therapy in Cancer-Related Venous Thromboembolism (VTE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Questionnaires
- description
- 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).
- interventionNames
- Behavioral: Questionnaires
Primary outcomes (1)
- measure
- Self-Reported Adherence to Anticoagulation
- timeFrame
- Baseline up to 6 months
- description
- Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale.
Secondary outcomes (1)
- measure
- HRQL Variables in Patients for Cancer-Related VTE Treated with Anticoagulation
- timeFrame
- Baseline, 3 months, and 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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