Clinical trial NCT03407469: Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer-related Venous Thromboembolism
Keywords: Questionnaires
Surveys
Cancer-related Venous Thromboembolism
VTE
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants treated for cancer-related VTE at UT MD Anderson Cancer Center and other institutions.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Self-Reported Adherence to Anticoagulation
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: HRQL Variables in Patients for Cancer-Related VTE Treated with Anticoagulation
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Cali
country: Colombia
facility: Fundacion Valle del Lili
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Carrer De Villarroel, 170
city: Barcelona,
country: Spain
facility: Hospital German Trias i Pujol
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Cristhiam M. Rojas Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: