NCT03407469

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2018Dec 2026

Study Start

First participant enrolled

January 12, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

9 years

First QC Date

January 16, 2018

Last Update Submit

May 18, 2026

Conditions

Cancer-related Venous Thromboembolism

Keywords

QuestionnairesSurveysCancer-related Venous ThromboembolismVTE

Outcome Measures

Primary Outcomes (1)

  • Self-Reported Adherence to Anticoagulation

    Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale.

    Baseline up to 6 months

Secondary Outcomes (1)

  • HRQL Variables in Patients for Cancer-Related VTE Treated with Anticoagulation

    Baseline, 3 months, and 6 months

Study Arms (1)

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

Interventions

QuestionnairesBEHAVIORAL

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.

Also known as: Surveys
Questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants treated for cancer-related VTE at UT MD Anderson Cancer Center and other institutions.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Fundacion Valle del Lili

Cali, Colombia

RECRUITING

Hospital Clinic

Barcelona, Carrer de Villarroel, 170, 08036, Spain

RECRUITING

Hospital German Trias i Pujol

Barcelona, 08916, Spain

RECRUITING

Related Links

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Cristhiam M. Rojas Hernandez, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristhiam M. Rojas Hernandez, MD

CONTACT

713-563-3070cmrojas@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 23, 2018

Study Start

January 12, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations

ES(2)CO(1)US(1)