Understanding quality of life and healthcare costs for cancer-related blood clots
Measurement of Adherence and Health-related Quality of Life, and Health-Care Resource Utilization During Anticoagulation Therapy in Cancer-Related Venous Thromboembolism (VTE)
This study is trying to understand how living with cancer-related blood clots affects people's quality of life and healthcare costs by gathering information from patients over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 4 sites (Houston, Texas and 3 other locations) |
| Trial ID | NCT03407469 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life, treatment experiences, and healthcare resource utilization among patients undergoing long-term treatment for cancer-related venous thromboembolism (VTE). Participants will complete questionnaires at various intervals over a year to gather data on their health-related quality of life and experiences with VTE treatment. The study will enroll up to 260 participants across multiple centers, with a significant portion from MD Anderson Cancer Center. Medical records will also be reviewed to complement the questionnaire data.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed symptomatic venous thromboembolism related to cancer who are starting long-term anticoagulation treatment.
Not a fit: Patients without a recent diagnosis of cancer or those not receiving anticoagulation treatment for VTE may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into improving the quality of life and treatment strategies for patients with cancer-related VTE.
How similar studies have performed: Other studies have explored quality of life in cancer patients, indicating potential for success in understanding the impact of VTE treatment.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Houston, Texas and 3 other locations
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Fundacion Valle del Lili — Cali, Colombia (Recruiting)
- Hospital Clinic — Barcelona, Carrer de Villarroel, 170, Spain (Recruiting)
- Hospital German Trias i Pujol — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Cristhiam M. Rojas Hernandez, MD — M.D. Anderson Cancer Center
- Study coordinator: Cristhiam M. Rojas Hernandez, MD
- Email: cmrojas@mdanderson.org
- Phone: 713-563-3070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.