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

May 18, 2026 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Colombia
      • Cali, Colombia
  • Spain
    • Carrer de Villarroel, 170
      • Barcelona, Carrer de Villarroel, 170, Spain, 08036
        • Recruiting
        • Hospital Clinic
        • Contact:
          • Carme Font, MD
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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 5 days 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Surveys

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-Reported Adherence to Anticoagulation
Time Frame: Baseline up to 6 months
Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale.
Baseline up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cristhiam M. Rojas Hernandez, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-0303
  • NCI-2018-00900 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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