Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study

NCT ID: NCT07215624

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-02

Study Completion Date

2027-06-01

Brief Summary

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This study evaluates the use of extended venous thromboembolism prophylaxis (ePPx) following abdominopelvic cancer surgery within the NCI Community Oncology Research Program (NCORP) network, targeting surgeons and surgical advanced practice providers (APPs).

Detailed Description

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PRIMARY OBJECTIVE:

I. To evaluate self-reported utilization of guideline concordant extended venous thromboembolism (VTE) prophylaxis (ePPx) following abdominopelvic cancer surgery within a sample of surgeons practicing within NCORP based on the Part 1 surgeon survey.

SECONDARY OBJECTIVES:

I. Evaluate site factors (e.g., proportion of publicly insured patients, proportion of Black patients, presence of a medical school, NCI designation) and surgeon factors (e.g., fellowship training, years in practice) associated with surgeon self-reported guideline concordant ePPx utilization (Part 1).

II. Conduct semi-structured interviews among a subset of surgeons and surgical APPs to assess: 1) Barriers/facilitators toward ePPx after cancer surgery and 2) Acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2).

III. Extract EHR data from select practices to assess the feasibility of query-based electronic health record (EHR) data extraction for identification of (i) patients undergoing cancer surgery, and (ii) prescription of guideline concordant ePPx among eligible patients (Part 3).

OUTLINE: This is an observational study.

PART 1: Surgeons and APPs complete a survey on study. After completion of surgeon or APP survey, site contact person or Cancer Care Delivery Research (CCDR) lead complete site surveys on study.

PART 2: A subset of surgeons and APPs from part 1 complete a semi-structured interview on study.

PART 3: Site contact person or CCDR lead complete a survey to identify a EHR Report Specialist on study. EHR Report Specialist performs an EHR Data Extraction and provides feedback on the process in a survey.

Conditions

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Malignant Digestive System Neoplasm Malignant Female Reproductive System Neoplasm Malignant Genitourinary System Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Part 1

Surgeons and APPs complete a survey on study. After completion of surgeon or APP survey, site contact person or CCDR lead complete site surveys on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Observational Part 2

Subset of surgeons and APPs from Part 1 complete a semi-structured interview on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Observational Part 3

Site contact person or CCDR lead complete a survey to identify a EHR Report Specialist on study. EHR Report Specialist performs an EHR Data Extraction and provides feedback on the process in a survey.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Other Intervention Names

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Non-Interventional Observational Study Noninterventional (Observational) Study Non-Interventional Observational Study Noninterventional (Observational) Study Non-Interventional Observational Study Noninterventional (Observational) Study

Eligibility Criteria

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Inclusion Criteria

SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:

\* Any surgeon performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgeons do not need to be involved in research or have a Cancer Therapy Evaluation Program Identification (CTEP ID) to participate in this study

SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 0 ENROLLMENT:

\* APPs providing postoperative care to patients operated by surgeons performing gastrointestinal, genitourinary, or gynecologic cancer surgery within an NCORP site, including general surgeons, surgical specialists, urologists, and gynecologists. Surgical APPs do not need to be involved in research or have a CTEP ID to participate in this study

SURGEON ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:

\* Must have completed the STOP-VTE Survey - Surgeon electronically (preferred) or on paper and have it transferred to Research Electronic Data Capture (REDCap) by the contact person(s)

SURGICAL APP ELIGIBILITY CRITERIA FOR OPEN STEP 1 ENROLLMENT:

\* Must have completed the STOP-VTE Survey - APP electronically (preferred) or on paper and have it transferred to REDCap by the contact person(s)

SITE ELIGIBILITY PART 1-SITE ENROLLMENT IN OPEN:

\* Have at least one eligible surgeon or surgical APP who completed the STOP-VTE Survey - Surgeon/APP

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn Lesser, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

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Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status RECRUITING

Wake Forest NCORP Research Base

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karen Craver

Role: CONTACT

336-716-0891

Facility Contacts

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Role: primary

515-358-6613

Kathryn E Weaver, PhD

Role: primary

336-716-0891

Karen T Craver, MT,MHA

Role: backup

336-716-0891

Role: primary

864-522-4317

Other Identifiers

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NCI-2025-06376

Identifier Type: OTHER

Identifier Source: secondary_id

WF-2502CD

Identifier Type: OTHER

Identifier Source: secondary_id

WF-2502CD

Identifier Type: OTHER

Identifier Source: secondary_id

WF-2502CD

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00138219

Identifier Type: -

Identifier Source: org_study_id

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