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RecruitingNCT03407469Updated Nov 10, 2026

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

An observational study in Cancer-related Venous Thromboembolism, sponsored by M.D. Anderson Cancer Center. Recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by M.D. Anderson Cancer Center · Observational

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
260
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer-related Venous Thromboembolism

Keywords

  • Questionnaires
  • Surveys
  • Cancer-related Venous Thromboembolism
  • VTE
03

In context

Venous Thromboembolism

712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.

This study's planned enrollment of 260 is below the median of 700 across 282 observational studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and complete study survey tools
  7. Able to read and speak English.

Exclusion criteria

Exclusion Criteria:

  1. Indication for anticoagulation other than cancer-related VTE.
  2. An (ECOG) Performance Status of 4 at the time of study enrollment.
  3. \< 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
260 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralQuestionnaires

    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

06

What researchers measure

Primary outcomes

  1. Self-Reported Adherence to Anticoagulation

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

    Time frame: Baseline up to 6 months

Secondary outcomes

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

    The HRQL variables measured using a deep venous thrombosis quality of life questionnaire: DVTQOL.

    Time frame: Baseline, 3 months, and 6 months

07

Study locations

4 of 4 sites recruiting
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03407469
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Jan 12, 2018
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 10, 2026

Study contacts

Cristhiam M. Rojas Hernandez, MD
Contact
cmrojas@mdanderson.org
713-563-3070
Cristhiam M. Rojas Hernandez, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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