Cancer-related Venous ThromboembolismNCT03407469
Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
An observational study of Cancer-related Venous Thromboembolism, run by M.D. Anderson Cancer Center at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Venous Thromboembolism
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 260 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 12 Jan 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants treated for cancer-related VTE at UT MD Anderson Cancer Center and other institutions.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clinic
Barcelona, Carrer de Villarroel, 170, 08036
Carme Font, MD
- Recruiting
Hospital German Trias i Pujol
Barcelona, 08916
: Juan J Lopez Nuñez, MD
jjlopez.germanstrias@gencat.cat
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Cristhiam M Rojas Hernandez, MD, cmrojas@mdanderson.org
Colombia1 site, 1 recruiting
- Recruiting
Fundacion Valle del Lili
Cali
Juan E Gomez-Mesa, MD
juanestebang@yahoo.com
About this study
Official title: 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.
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.
- Conditions
- Cancer-related Venous Thromboembolism
- Being tested
- Questionnaires
- Keywords
- Questionnaires, Surveys, Cancer-related Venous Thromboembolism, VTE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Adherence to Anticoagulation
Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale.
Measured: 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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start12 Jan 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristhiam M. Rojas Hernandez, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407469
- Sponsor's protocol ID
- 2017-0303
- Other IDs
- NCI-2018-00900
- Status last verified
- May 2026
- First submitted
- 16 Jan 2018
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Adherence and Health-related Quality of Life, and Health-Care Resource Utilization During Anticoagulation Therapy in Cancer-Related Venous Thromboembolism (VTE)
- ClinicalTrials.gov ID
- NCT03407469
- Acronym / sponsor ID
- 2017-0303
- Conditions
- Cancer-related Venous Thromboembolism
- Keywords
- Questionnaires, Surveys, Cancer-related Venous Thromboembolism, VTE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires | – | Behavioral: QuestionnairesQuestionnaires 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants treated for cancer-related VTE at UT MD Anderson Cancer Center and other institutions.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: SurveysQuestionnaires 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. | Behavioural | Questionnaires |
Primary outcome
Self-Reported Adherence to Anticoagulation
Time frame: Baseline up to 6 months
Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale.
1 secondary outcome
HRQL Variables in Patients for Cancer-Related VTE Treated with Anticoagulation
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Cancer-related Venous Thromboembolism
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Safety of Perioperative Anticoagulation Management in People With Active Cancer Undergoing Cancer-Related Surgery or Procedures (ACE-HIGH Study)
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Cancer-related Venous Thromboembolic Disease - Cohort Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristhiam M. Rojas Hernandez, MD principal investigator
M.D. Anderson Cancer Center
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Venous Thromboembolism, run by M.D. Anderson Cancer Center at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, United States, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristhiam M. Rojas Hernandez, MD (713-563-3070, cmrojas@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Adherence to Anticoagulation (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.