Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
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|ClinicalTrials.gov Identifier: NCT03407469|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
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.
|Condition or disease||Intervention/treatment|
|Cancer-related Venous Thromboembolism||Behavioral: Questionnaires|
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.
|Study Type :||Observational|
|Estimated Enrollment :||260 participants|
|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)|
|Actual Study Start Date :||January 12, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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).
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.
Other Name: Surveys
- Self-Reported Adherence to Anticoagulation [ Time Frame: Baseline up to 6 months ]Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale.
- HRQL Variables in Patients for Cancer-Related VTE Treated with Anticoagulation [ Time Frame: Baseline, 3 months, and 6 months ]The HRQL variables measured using a deep venous thrombosis quality of life questionnaire: DVTQOL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407469
|Contact: Cristhiam M. Rojas Hernandez, MD||713-563-3070||CR_Study_Registration@mdanderson.org|
|United States, Alabama|
|Mitchell Cancer Institute||Recruiting|
|Mobile, Alabama, United States, 36604|
|Contact: Thomas W. Butler, MD|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations CR_Study_Registration@mdanderson.org|
|Barcelona, Carrer De Villarroel, 170, Spain, 08036|
|Contact: Carme Font, MD|
|Principal Investigator:||Cristhiam M. Rojas Hernandez, MD||M.D. Anderson Cancer Center|