RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2018-01-12

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03407469

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 72 hours from initiation of anticoagulation. 6. Able to provide informed consent and complete study survey tools 7. Able to read and speak English.	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.

Inclusion Criteria

Exclusion 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 72 hours from initiation of anticoagulation.
6. Able to provide informed consent and complete study survey tools
7. Able to read and speak English.

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.

Contacts and Locations

Study Contact

Cristhiam M. Rojas Hernandez, MD

CONTACT

713-563-3070

cmrojas@mdanderson.org

Principal Investigator

Cristhiam M. Rojas Hernandez, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Cristhiam M. Rojas Hernandez, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2018-01-12

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2018-01-12

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Questionnaires
Surveys
Cancer-related Venous Thromboembolism
VTE

Additional Relevant MeSH Terms

Cancer-related Venous Thromboembolism