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Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer (CANVAS)

Primary Purpose

Cancer, Venous Thromboembolism, Deep Vein Thrombosis (DVT)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rivaroxaban
Apixaban
Edoxaban
Dabigatran
Warfarin
Dalteparin
Enoxaparin
Fondaparinux
Sponsored by
Alliance Foundation Trials, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Rivaroxaban (Xarelto), Apixaban (Eliquis), Edoxaban (Savaysa), Dabigatran (Pradaxa), Warfarin (Coumadin), Low molecular weight heparin (LMWH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma <= 12 months prior to study enrollment

  • Diagnosis of VTE <= 30 days prior to study enrollment for which potential benefits of anticoagulation therapy to prevent recurrence of VTE are felt by the treating physician to exceed the potential harms

    • Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= 30days after the index VTE diagnosis date
  • Treating physician intends to put participant on anticoagulation therapy for at least three months.
  • Age >= 18 years
  • Platelet count is >= 50,000/mm^3 (<= 7 days prior to enrollment)
  • CrCl (Creatinine Clearance) is >= 15 ml/min (<= 7 days prior to enrollment)

Exclusion Criteria:

  • Diagnosis of acute leukemia

  • Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)

    • Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible.
    • Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible
  • Ongoing, clinically significant bleeding (CTCAE grade 3 or 4)
  • Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors
  • Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment

Sites / Locations

  • South County Hematology
  • Sharp Rees-Stealy
  • Washington Hospital Healthcare System
  • Washington Hospital
  • VA Central California Fresno Medical Center
  • Cancer Center Oncology Medical Group
  • Medical Oncology Associates- San Diego
  • Sharp Memorial Hospital
  • Sharp Rees-Stealy
  • UCSF Medical Center - Mission Bay
  • Saint Joseph's Medical Center
  • Middlesex Hospital
  • The Stamford Hospital
  • Morton Plant Hospital
  • Breast Cancer Center at Memorial Regional Hospital
  • Memorial Cancer Institute at Memorial Regional Hospital
  • Memorial Regional Hospital
  • Hollis Cancer Center
  • Breast Cancer Center at Memorial Hospital West
  • Memorial Cancer Institute at Memorial Hospital West
  • Memorial Hospital West
  • The Center for Cancer Care-Duluth
  • Gwinnett Medical Center
  • The Center for Cancer Care-Snellville
  • Hawaii Cancer Care POB II
  • Hawaii Oncology Inc POB I
  • Queen's Medical Center
  • University of Hawaii Cancer Center
  • Hawaii Cancer Care Liliha
  • Hawaii Oncology Inc Kuakini
  • Kootenai Health
  • University of Illinois
  • Advocate Illinois Masonic Medical Center
  • Carle on Vermillion
  • Carle - Effingham
  • NorthShore University HealthSystem Evanston Hospital
  • NorthShore University HealthSystem Glenbrook Hospital
  • NorthShore University HealthSystem Highland Park Hospital
  • Carle - Mattoon/Charleston
  • Loyola University Medical Center
  • NorthShore University HealthSystem Skokie ACC
  • The Carle Foundation Hospital/Carle Cancer Center
  • Franciscan St. Francis Health - Indianapolis
  • Woodland Cancer Care Center
  • Franciscan St. Francis Health - Mooresville
  • Reid Health
  • Memorial Hospital at South Bend
  • Union Hospital
  • Saint Elizabeth Medical Center South
  • Saint Elizabeth Medical Center Fort Thomas
  • Chandler Medical Center - University of Kentucky
  • James Graham Brown Cancer Center
  • Norton Hospital
  • University of Louisville Hospital
  • University of Louisville Physicians, PSC
  • University of Louisville, Division of Surgical Oncology
  • Eastern Maine Medical Center
  • University of Maryland Medical Center
  • Walter Reed National Military Medical Center
  • DF/BWCC at Milford Regional Medical Center
  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • Dana-Farber Cancer Institute
  • St. Elizabeth's Medical Center
  • Lowell General Hospital
  • South Shore Hospital
  • Henry Ford Health System
  • Green Bay Oncology, Ltd./St. Francis Hospital
  • Masonic Cancer Center University of Minnesota Medical Center
  • University of Minnesota Health: Clinics and Surgery Center
  • University of Minnesota Medical Center, Fairview
  • Veterans Administration/Harry S Truman Memorial Hospital
  • Ellis Fischel Cancer Center University of Missouri Healthcare
  • Washington University School of Medicine
  • Siteman Cancer Center - South County
  • Siteman Cancer Center - West County
  • Siteman Cancer Center - St. Peters
  • Community Hospital of Anaconda
  • Billings Clinic
  • Montana Cancer Consortium
  • Bozeman Health
  • Benefis Sletten Cancer Institute
  • Kalispell Regional Medical Center
  • Community Medical Center
  • Nevada Cancer Specialists - Oakey
  • Ann M Wierman MD LTD
  • Nevada Cancer Specialists - Tenaya
  • Comprehensive Cancer Centers of Nevada
  • Nevada Cancer Specialists - Fort Apache
  • Comprehensive Cancer Centers of Nevada - Central Valley
  • New Hampshire Oncology - Hematology PA
  • New Hampshire Oncology-Hematology PA
  • Dartmouth Hitchcock Medical Center
  • Dana-Farber/New Hampshire Oncology Hematology
  • Hackensack University Medical Center
  • John Theurer Cancer Center at Hackensack University Medical Center
  • University of New Mexico Cancer Center
  • Roswell Park Cancer Institute
  • SUNY Upstate Medical University
  • Mission Hospital - Memorial Campus
  • Southeastern Medical Oncology Center
  • Duke University Health System
  • Southeastern Medical Oncology Center
  • East Carolina University
  • Southeastern Medical Oncology Center
  • Kenansville Medical Center
  • Kinston Medical Specialists, P.A.
  • Lenoir Memorial Hospital
  • Onslow Medical Center
  • Wake Forest Baptist Health
  • Dayton Physicians LLC, Miami Valley South
  • The James Cancer Hospital and Solove Research Institute
  • Dayton Physicians LLC, Samaritan North
  • Dayton Clincial Oncology Program
  • Veteran Affairs Medical Center
  • Wright Patterson Medical Center
  • Dayton Physicians LLC, Atrium
  • Dayton Physicians, Wayne
  • Greater Dayton Cancer Center
  • Kettering Medical Center
  • Toledo Clinic Cancer Center - Maumee
  • Toledo Clinic Cancer Center - Toledo
  • Dayton Physicians LLC, Upper valley
  • WellSpan Health Ephrata Cancer Center
  • WellSpan Health Adams Cancer Center
  • WellSpan Health Sechler Family Cancer Center
  • Western Pennsylvania Hospital
  • WellSpan Health York Cancer Center
  • Baylor Scott & White Research Institute
  • Baylor University Medical Center
  • University of Texas Southwestern Medical Center
  • University of Vermont Medical Center
  • Augusta Health Cancer Center
  • Fort Belvoir Community Hospital
  • Bon Secours Cancer Institute Medical Oncology at Memorial Regional
  • Bon Secours Cancer Institute Medical Oncology at St. Francis
  • Bon Secours Cancer Institute Medical Oncology at St. Mary's
  • MultiCare Regional Cancer Center - Auburn
  • MultiCare Regional Cancer Center - Gig Harbor Medical Park
  • MultiCare Regional Cancer Center - Puyallup
  • Multicare Institute for Research & Innovation
  • MultiCare Regional Cancer Center - Tacoma
  • Green Bay Oncology, Ltd./HSHS St. Vincent Hospital
  • HSHS St. Vincent Hospital
  • Green Bay Oncology, Ltd./HSHS St. Mary's Hospital Medical Center
  • HSHS St. Mary's Hospital Medical Center
  • Gundersen Lutheran Medical Center
  • University of Wisconsin
  • Medical College of Wisconsin
  • Green Bay Oncology, Ltd./HSHS St. Clare Memorial Hospital
  • Green Bay Oncology, Ltd./Door County Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Randomized Arm 1 (DOACs)

Randomized Arm 2 (LMWH)

Preference Cohort 1 (DOACs)

Preference Cohort 2 (LMWH)

Arm Description

Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.

Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.

If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized). Preference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).

If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized). Preference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.

Outcomes

Primary Outcome Measures

Cumulative Non-Fatal VTE Recurrence at 6 Months (%)
To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE.

Secondary Outcome Measures

Cumulative Rates of Major Bleeding
To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months. d. Major bleeding was defined as Grade >=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living).
Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
Change in physical health at 3 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 3-month follow-up assessment.
Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).
Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)
To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months. Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form)
Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
Change in physical health at 6 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 6-month follow-up assessment.
Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).
Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).
Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).
Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months
Change in mental health at 3 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.
Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months
Change in mental health at 6 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.

Full Information

First Posted
April 11, 2016
Last Updated
September 8, 2023
Sponsor
Alliance Foundation Trials, LLC.
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02744092
Brief Title
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer
Acronym
CANVAS
Official Title
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2016 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
February 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance Foundation Trials, LLC.
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.
Detailed Description
Venous blood clots affect nearly a million Americans each year. Venous clots in the legs are called deep venous thrombosis (DVT) and are dangerous because they travel to the lungs where they cause blockages known as pulmonary emboli (PE). DVT and PE are called venous thromboemboli (VTE). Cancer is a risk factor with nearly 200,000 VTEs in cancer patients each year. The purpose of VTE treatment is to prevent the initial clot from spreading and to prevent new clots from forming. This is accomplished by thinning the blood, or anticoagulation. Without anticoagulation, VTEs recur and are often fatal. Recently, the FDA has approved 4 new Direct Oral AntiCoagulants (DOACs) for preventing VTE recurrence. Few cancer patients were included in the efficacy trials, and practice guidelines fall silent on whether switching to DOAC therapy is advisable. To fill this knowledge gap, the Alliance Foundation Trials LLC, a research network of academic and community practices across the US, is conducting a pragmatic randomized effectiveness trial. The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The investigators will conduct a trial of 811 cancer patients followed for 6 months. The intervention strategy is DOAC therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is LMWH alone or with warfarin. Within each arm, patients can choose the agent they prefer based on side effects, drug interactions, and practical issues such as co-pays. The trial compares these two strategies in terms of treatment: 1) benefits based on VTE recurrence; 2) harms based on bleeding rates; 3) burdens based on patients' reports of their experiences; and 4) mortality rates. The investigators hypothesize that the benefits, harms and burdens of DOAC treatment will be non-inferior to, or better than, usual care with LMWH/ warfarin among cancer patients. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Venous Thromboembolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Blood Clot
Keywords
Rivaroxaban (Xarelto), Apixaban (Eliquis), Edoxaban (Savaysa), Dabigatran (Pradaxa), Warfarin (Coumadin), Low molecular weight heparin (LMWH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
811 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized Arm 1 (DOACs)
Arm Type
Active Comparator
Arm Description
Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.
Arm Title
Randomized Arm 2 (LMWH)
Arm Type
Active Comparator
Arm Description
Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.
Arm Title
Preference Cohort 1 (DOACs)
Arm Type
Active Comparator
Arm Description
If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized). Preference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).
Arm Title
Preference Cohort 2 (LMWH)
Arm Type
Active Comparator
Arm Description
If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized). Preference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Intervention Description
Anticoagulation therapy.
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis
Intervention Description
Anticoagulation therapy.
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
Savaysa
Intervention Description
Anticoagulation therapy.
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Other Intervention Name(s)
Pradaxa
Intervention Description
Anticoagulation therapy.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
Anticoagulation therapy.
Intervention Type
Drug
Intervention Name(s)
Dalteparin
Other Intervention Name(s)
Fragmin
Intervention Description
Anticoagulation therapy.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Lovenox
Intervention Description
Anticoagulation therapy.
Intervention Type
Drug
Intervention Name(s)
Fondaparinux
Other Intervention Name(s)
Arixtra
Intervention Description
Anticoagulation therapy.
Primary Outcome Measure Information:
Title
Cumulative Non-Fatal VTE Recurrence at 6 Months (%)
Description
To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cumulative Rates of Major Bleeding
Description
To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months. d. Major bleeding was defined as Grade >=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living).
Time Frame
6 months
Title
Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
Description
Change in physical health at 3 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 3-month follow-up assessment.
Time Frame
3 months
Title
Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
Description
To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).
Time Frame
3 months
Title
Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)
Description
To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months. Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form)
Time Frame
6 months
Title
Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
Description
Change in physical health at 6 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 6-month follow-up assessment.
Time Frame
6 months
Title
Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
Description
To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).
Time Frame
6 months
Title
Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
Description
To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).
Time Frame
3-months
Title
Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
Description
To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).
Time Frame
6-months
Title
Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months
Description
Change in mental health at 3 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.
Time Frame
3-months
Title
Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months
Description
Change in mental health at 6 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma <= 12 months prior to study enrollment Diagnosis of VTE <= 30 days prior to study enrollment for which potential benefits of anticoagulation therapy to prevent recurrence of VTE are felt by the treating physician to exceed the potential harms Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= 30days after the index VTE diagnosis date Treating physician intends to put participant on anticoagulation therapy for at least three months. Age >= 18 years Platelet count is >= 50,000/mm^3 (<= 7 days prior to enrollment) CrCl (Creatinine Clearance) is >= 15 ml/min (<= 7 days prior to enrollment) Exclusion Criteria: Diagnosis of acute leukemia Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible. Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible Ongoing, clinically significant bleeding (CTCAE grade 3 or 4) Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Schrag, MD MPH
Organizational Affiliation
Alliance Foundation Trials, LLC.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean Connors, MD
Organizational Affiliation
Alliance Foundation Trials, LLC.
Official's Role
Study Chair
Facility Information:
Facility Name
South County Hematology
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Sharp Rees-Stealy
City
Chula Vista
State/Province
California
ZIP/Postal Code
91913
Country
United States
Facility Name
Washington Hospital Healthcare System
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Washington Hospital
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
VA Central California Fresno Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93073
Country
United States
Facility Name
Cancer Center Oncology Medical Group
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Medical Oncology Associates- San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Rees-Stealy
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Medical Center - Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Saint Joseph's Medical Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Middlesex Hospital
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
The Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Breast Cancer Center at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Hollis Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Breast Cancer Center at Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
The Center for Cancer Care-Duluth
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Gwinnett Medical Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
The Center for Cancer Care-Snellville
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Hawaii Cancer Care POB II
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Hawaii Oncology Inc POB I
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Hawaii Cancer Care Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Hawaii Oncology Inc Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kootenai Health
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Advocate Illinois Masonic Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Carle on Vermillion
City
Danville
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Carle - Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
NorthShore University HealthSystem Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
NorthShore University HealthSystem Glenbrook Hospital
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
NorthShore University HealthSystem Highland Park Hospital
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Carle - Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
NorthShore University HealthSystem Skokie ACC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
The Carle Foundation Hospital/Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Franciscan St. Francis Health - Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Woodland Cancer Care Center
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Franciscan St. Francis Health - Mooresville
City
Mooresville
State/Province
Indiana
ZIP/Postal Code
46158
Country
United States
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Memorial Hospital at South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Union Hospital
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804
Country
United States
Facility Name
Saint Elizabeth Medical Center South
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Saint Elizabeth Medical Center Fort Thomas
City
Fort Thomas
State/Province
Kentucky
ZIP/Postal Code
41075
Country
United States
Facility Name
Chandler Medical Center - University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Physicians, PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville, Division of Surgical Oncology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
DF/BWCC at Milford Regional Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Lowell General Hospital
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Facility Name
South Shore Hospital
City
South Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Green Bay Oncology, Ltd./St. Francis Hospital
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49829
Country
United States
Facility Name
Masonic Cancer Center University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Minnesota Health: Clinics and Surgery Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Minnesota Medical Center, Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Veterans Administration/Harry S Truman Memorial Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Ellis Fischel Cancer Center University of Missouri Healthcare
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Siteman Cancer Center - West County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Siteman Cancer Center - St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Community Hospital of Anaconda
City
Anaconda
State/Province
Montana
ZIP/Postal Code
59711
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Bozeman Health
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Benefis Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Nevada Cancer Specialists - Oakey
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Ann M Wierman MD LTD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Nevada Cancer Specialists - Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Nevada Cancer Specialists - Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Central Valley
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
New Hampshire Oncology - Hematology PA
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
New Hampshire Oncology-Hematology PA
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Dana-Farber/New Hampshire Oncology Hematology
City
Londonderry
State/Province
New Hampshire
ZIP/Postal Code
03053
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
SUNY Upstate Medical University
City
New York
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Mission Hospital - Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Clinton
State/Province
North Carolina
ZIP/Postal Code
28328
Country
United States
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Kenansville Medical Center
City
Kenansville
State/Province
North Carolina
ZIP/Postal Code
28349
Country
United States
Facility Name
Kinston Medical Specialists, P.A.
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Lenoir Memorial Hospital
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Onslow Medical Center
City
Richlands
State/Province
North Carolina
ZIP/Postal Code
28574
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Dayton Physicians LLC, Miami Valley South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
The James Cancer Hospital and Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Dayton Physicians LLC, Samaritan North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Dayton Clincial Oncology Program
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Veteran Affairs Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
Wright Patterson Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45433
Country
United States
Facility Name
Dayton Physicians LLC, Atrium
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Dayton Physicians, Wayne
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Greater Dayton Cancer Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Toledo Clinic Cancer Center - Maumee
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Toledo Clinic Cancer Center - Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Dayton Physicians LLC, Upper valley
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
WellSpan Health Ephrata Cancer Center
City
Ephrata
State/Province
Pennsylvania
ZIP/Postal Code
17522
Country
United States
Facility Name
WellSpan Health Adams Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
WellSpan Health Sechler Family Cancer Center
City
Lebanon
State/Province
Pennsylvania
ZIP/Postal Code
17042
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
WellSpan Health York Cancer Center
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Augusta Health Cancer Center
City
Fishersville
State/Province
Virginia
ZIP/Postal Code
22939
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Bon Secours Cancer Institute Medical Oncology at Memorial Regional
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Bon Secours Cancer Institute Medical Oncology at St. Francis
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Bon Secours Cancer Institute Medical Oncology at St. Mary's
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
MultiCare Regional Cancer Center - Auburn
City
Auburn
State/Province
Washington
ZIP/Postal Code
98001
Country
United States
Facility Name
MultiCare Regional Cancer Center - Gig Harbor Medical Park
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
Facility Name
MultiCare Regional Cancer Center - Puyallup
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Multicare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
MultiCare Regional Cancer Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Green Bay Oncology, Ltd./HSHS St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
HSHS St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Green Bay Oncology, Ltd./HSHS St. Mary's Hospital Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
HSHS St. Mary's Hospital Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Green Bay Oncology, Ltd./HSHS St. Clare Memorial Hospital
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Green Bay Oncology, Ltd./Door County Memorial Hospital
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54135
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual-level de-identified datasets will be made available to investigators working under an institution with a Federal Wide Assurance (FWA) who formally submit a request to the study chairs at the Dana-Farber Cancer Institute. Prior to the release of datasets, DFCI will ensure certain requirements, e.g., IRB approval and data use agreement, are in place. These datasets will be available within 6 months of publication of the manuscript and following a formal request by an investigator to and approval from DFCI.
IPD Sharing Time Frame
within 6 months of publication of the manuscript, no end date
IPD Sharing Access Criteria
following a formal request by an investigator to and approval from DFCI
Citations:
PubMed Identifier
34172290
Citation
Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22.
Results Reference
derived
Links:
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s001lbl.pdf
Description
FDA Package Insert for Rivaroxaban (Xarelto)
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf
Description
FDA Package Insert for Apixaban (Eliquis)
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf
Description
FDA Package Insert for Edoxaban (Savaysa)
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s007lbl.pdf
Description
FDA Package Insert for Dabigatran (Pradaxa)
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020287s050lbl.pdf
Description
FDA Package Insert for Dalteparin (Fragmin)
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s083lbl.pdf
Description
FDA Package Insert for Enoxaparin (Lovenox)
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021345s023lbl.pdf
Description
FDA Package Insert for Fondaparinux (Arixtra)
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf
Description
FDA Package Insert for Warfarin (Coumadin)
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.allianceforclinicaltrialsinoncology.org/main/public/standard.xhtml?path=%2FPublic%2FAFT
Available IPD/Information Identifier
AFT-28
Available IPD/Information Comments
Email the study team at CANVAS@AllianceFoundationTrials.org.

Learn more about this trial

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer

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