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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
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment
Cancer-related Venous Thromboembolism Behavioral: Questionnaires

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.


Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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).
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.
Other Name: Surveys




Primary Outcome Measures :
  1. Self-Reported Adherence to Anticoagulation [ Time Frame: Baseline up to 6 months ]
    Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants treated for cancer-related VTE at UT MD Anderson Cancer Center and other institutions.
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 72 hours 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.

Information from the National Library of Medicine

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


Contacts
Contact: Cristhiam M. Rojas Hernandez, MD 713-563-3070 CR_Study_Registration@mdanderson.org

Locations
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   
Spain
Hospital Clinic Recruiting
Barcelona, Carrer De Villarroel, 170, Spain, 08036
Contact: Carme Font, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Cristhiam M. Rojas Hernandez, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03407469     History of Changes
Other Study ID Numbers: 2017-0303
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Questionnaires
Surveys
Cancer-related Venous Thromboembolism
VTE

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases