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Идёт набор NCT03407469

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

— Наблюдательное Cancer-related Venous Thromboembolism

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Questionnaires.
Кому может быть актуально
Состояния в реестре: Cancer-related Venous Thromboembolism. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Колумбия, Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Self-Reported Adherence to Anticoagulation [Срок оценки: Baseline up to 6 months]
Вторичные конечные точки (1)
  • HRQL Variables in Patients for Cancer-Related VTE Treated with Anticoagulation [Срок оценки: Baseline, 3 months, and 6 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 2 центра
  • Hospital Clinic — Barcelona
  • Hospital German Trias i Pujol — Barcelona
США · 1 центр
  • University of Texas MD Anderson Cancer Center — Houston
Колумбия · 1 центр
  • Fundacion Valle del Lili — Cali

Идентификаторы

NCT: NCT03407469 · 2017-0303 · NCI-2018-00900

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗