NCT07215624

Brief Summary

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jan 2026

Geographic Reach
2 countries

59 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

September 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

September 29, 2025

Last Update Submit

April 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-reported utilization of guideline concordant ePPx for surgeons (Part 1)

    Will apply only to surgeons completing the Part 1 survey. Will be defined as answering "Yes, all cases or almost all cases" on the survey question asking about prescription of ePPx after discharge. The proportion of surgeons self-reporting utilization of guideline concordant ePPx will be estimated and reported along with an exact 95% confidence interval.

    After 1 year from start of Part 1

Secondary Outcomes (3)

  • Self-reported utilization of guideline concordant ePPx for surgeons within strata defined by site and surgeon factors (Part 1)

    After 1 year from start of Part 1

  • Barriers and facilitators toward ePPx after cancer surgery, and acceptability of clinical decision support tools to support VTE prophylaxis prescribing (Part 2)

    After 6 months from start of Part 2

  • Feasibility (i.e., proportion of practices able to provide data) of EHR queries from selected practices to inform future trial (Part 3)

    After 6 months from start of Part 3

Study Arms (3)

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.

Other: Non-Interventional Study

Observational Part 2

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

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.

Other: Non-Interventional Study

Interventions

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study
Observational Part 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This multi-part study employs a mixed-methods design to evaluate the utilization of ePPx following abdominopelvic cancer surgery within the NCORP network. Part 1 involves a cross-sectional survey of at least 100 surgeons/APPs from at least 25 NCORP sites to evaluate practice patterns related to ePPx. Part 2 utilizes purposive sampling to conduct interviews with 11-25 surgeons/APPs from Part 1 to obtain granular detail about barriers and facilitators to guideline concordant utilization of ePPx. Part 3 will purposively sample 6 practices identified in Part 1 to evaluate the feasibility of EHR queries to assess ePPx utilization.

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (59)

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Augusta University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

Northside Hospital - Gwinnett

Lawrenceville, Georgia, 30046, United States

RECRUITING

Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

RECRUITING

Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

RECRUITING

MaineHealth Maine Medical Center - Portland

Portland, Maine, 04102, United States

RECRUITING

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States

RECRUITING

Christiana Care - Union Hospital

Elkton, Maryland, 02192, United States

RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

RECRUITING

Chelsea Hospital

Chelsea, Michigan, 48118, United States

RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

RECRUITING

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

RECRUITING

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337, United States

RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, 55805, United States

RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

RECRUITING

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369, United States

RECRUITING

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Health Partners Inc

Minneapolis, Minnesota, 55454, United States

RECRUITING

New Ulm Medical Center

New Ulm, Minnesota, 56073, United States

RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

United Hospital

Saint Paul, Minnesota, 55102, United States

RECRUITING

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

RECRUITING

Cox Cancer Center Branson

Branson, Missouri, 65616, United States

RECRUITING

Mercy Hospital Joplin

Joplin, Missouri, 64804, United States

RECRUITING

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri, 64116, United States

RECRUITING

Liberty Hospital

Liberty, Missouri, 64068, United States

RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, 65065, United States

RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

RECRUITING

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

RECRUITING

Mercy Hospital South

St Louis, Missouri, 63128, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

RECRUITING

Wake Forest NCORP Research Base

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220, United States

RECRUITING

Dayton Veterans Affairs Medical Center

Dayton, Ohio, 45428, United States

RECRUITING

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Charleston Oncology North Charleston

Charleston, South Carolina, 29406, United States

RECRUITING

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

RECRUITING

Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, 54729, United States

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States

RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

RECRUITING

San Patricio Medflix

Guaynabo, 00968, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Gastrointestinal NeoplasmsUrogenital Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Glenn Lesser, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Central Study Contacts

Karen Craver

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 10, 2025

Study Start

January 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

Time Frame
6 months after publication for a 2 year duration
Access Criteria
upon request to NCORP@wakehealth.edu

Locations