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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Malignant Female Reproductive System Neoplasm; Malignant Genitourinary System Neoplasm; Malignant Digestive System Neoplasm

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07215624

WF-2502CD (Other Identifier)

IRB00138219

NCI-2025-06376 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Observational Part 1

Description:

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.

Treatment:

Other: Non-Interventional Study

Other: Non-Interventional Study

Other: Non-Interventional Study

Observational Part 2

Description:

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

Treatment:

Other: Non-Interventional Study

Other: Non-Interventional Study

Other: Non-Interventional Study

Observational Part 3

Description:

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.

Treatment:

Other: Non-Interventional Study

Other: Non-Interventional Study

Other: Non-Interventional Study