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NCT Number: NCT03407469

Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion Valle del Lili, Cali, Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (≥ 18 years) female or male subjects.
  • 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.
  • 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.
  • Intention for long-term treatment (at least 3 months) with anticoagulation.
  • Participants will be enrolled in the study within the first 5 days from initiation of anticoagulation.
  • Able to provide informed consent and complete study survey tools
  • Able to read and speak English.

Exclusion criteria

  • Indication for anticoagulation other than cancer-related VTE.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of 4 at the time of study enrollment.
  • Life expectancy < 3 months.
  • 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.

Treatment and study plan

Questionnaires

Behavioral

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 names: Surveys

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cristhiam M. Rojas Hernandez, MD

CONTACT

[email protected]

713-563-3070

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Measurement of Adherence and Health-related Quality of Life, and Health-Care Resource Utilization During Anticoagulation Therapy in Cancer-Related Venous Thromboembolism (VTE)

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2018
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.