Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-06376 | Other Identifier | NCI Trial Identifier | |
| WF-2502CD | Other Identifier | Lead Organization Identifier | |
| WF-2502CD | Other Identifier | DCP Identifier | |
| WF-2502CD | Other Identifier | CTEP Identifier |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Observational Part 2 | Subset of surgeons and APPs from Part 1 complete a semi-structured interview on 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported utilization of guideline concordant ePPx for surgeons within strata defined by site and surgeon factors (Part 1) | Self reported utilization as defined above for the primary outcome measure will be reported within strata defined by:
|
Not provided
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:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Craver | Contact | 336-716-0891 | NCORP@wfusm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Glenn Lesser, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Hospital Fort Smith | Recruiting | Fort Smith | Arkansas | 72903 | United States |
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.
Not provided
6 months after publication for a 2 year duration
upon request to NCORP@wakehealth.edu
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-Interventional Study | Other | Non-interventional study |
|
|
| Non-Interventional Study | Other | Non-interventional study |
|
|
| 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) | Themes from qualitative interviews by surgeons and APPs | 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) | Considered feasible if at least 4 of the 6 practices who agreed to participate are able to provide data on both patients undergoing cancer surgery and prescription of guideline concordant ePPx among eligible patients | After 6 months from start of Part 3 |
| Helen F Graham Cancer Center | Recruiting | Newark | Delaware | 19713 | United States |
|
| Medical Oncology Hematology Consultants PA | Recruiting | Newark | Delaware | 19713 | United States |
|
| Christiana Care Health System-Christiana Hospital | Recruiting | Newark | Delaware | 19718 | United States |
|
| Northside Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
|
| Augusta University Medical Center | Recruiting | Augusta | Georgia | 30912 | United States |
|
| Northside Hospital - Gwinnett | Recruiting | Lawrenceville | Georgia | 30046 | United States |
|
| Carle Cancer Center | Recruiting | Urbana | Illinois | 61801 | United States |
|
| Mercy Hospital | Recruiting | Cedar Rapids | Iowa | 52403 | United States |
|
| Oncology Associates at Mercy Medical Center | Recruiting | Cedar Rapids | Iowa | 52403 | United States |
|
| Blank Children's Hospital | Recruiting | Des Moines | Iowa | 50309 | United States |
|
| Iowa Methodist Medical Center | Recruiting | Des Moines | Iowa | 50309 | United States |
|
| Mercy Medical Center - Des Moines | Recruiting | Des Moines | Iowa | 50314 | United States |
|
| Iowa Lutheran Hospital | Recruiting | Des Moines | Iowa | 50316 | United States |
|
| MaineHealth Maine Medical Center - Portland | Recruiting | Portland | Maine | 04102 | United States |
|
| MaineHealth Maine Medical Center- Scarborough | Recruiting | Scarborough | Maine | 04074 | United States |
|
| Christiana Care - Union Hospital | Recruiting | Elkton | Maryland | 02192 | United States |
|
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Recruiting | Ann Arbor | Michigan | 48106 | United States |
|
| Chelsea Hospital | Recruiting | Chelsea | Michigan | 48118 | United States |
|
| Trinity Health Saint Mary Mercy Livonia Hospital | Recruiting | Livonia | Michigan | 48154 | United States |
|
| Trinity Health Saint Joseph Mercy Oakland Hospital | Recruiting | Pontiac | Michigan | 48341 | United States |
|
| Sanford Joe Lueken Cancer Center | Recruiting | Bemidji | Minnesota | 56601 | United States |
|
| Essentia Health Saint Joseph's Medical Center | Recruiting | Brainerd | Minnesota | 56401 | United States |
|
| Minnesota Oncology - Burnsville | Recruiting | Burnsville | Minnesota | 55337 | United States |
|
| Mercy Hospital | Recruiting | Coon Rapids | Minnesota | 55433 | United States |
|
| Essentia Health Saint Mary's Medical Center | Recruiting | Duluth | Minnesota | 55805 | United States |
|
| Fairview Southdale Hospital | Recruiting | Edina | Minnesota | 55435 | United States |
|
| Fairview Clinics and Surgery Center Maple Grove | Recruiting | Maple Grove | Minnesota | 55369 | United States |
|
| Minnesota Oncology Hematology PA-Maplewood | Recruiting | Maplewood | Minnesota | 55109 | United States |
|
| Abbott-Northwestern Hospital | Recruiting | Minneapolis | Minnesota | 55407 | United States |
|
| Hennepin County Medical Center | Recruiting | Minneapolis | Minnesota | 55415 | United States |
|
| Health Partners Inc | Recruiting | Minneapolis | Minnesota | 55454 | United States |
|
| New Ulm Medical Center | Recruiting | New Ulm | Minnesota | 56073 | United States |
|
| Park Nicollet Clinic - Saint Louis Park | Recruiting | Saint Louis Park | Minnesota | 55416 | United States |
|
| Regions Hospital | Recruiting | Saint Paul | Minnesota | 55101 | United States |
|
| United Hospital | Recruiting | Saint Paul | Minnesota | 55102 | United States |
|
| Lakeview Hospital | Recruiting | Stillwater | Minnesota | 55082 | United States |
|
| Minnesota Oncology Hematology PA-Woodbury | Recruiting | Woodbury | Minnesota | 55125 | United States |
|
| Cox Cancer Center Branson | Recruiting | Branson | Missouri | 65616 | United States |
|
| Mercy Hospital Joplin | Recruiting | Joplin | Missouri | 64804 | United States |
|
| University of Kansas Cancer Center - Briarcliff | Recruiting | Kansas City | Missouri | 64116 | United States |
|
| Liberty Hospital | Recruiting | Liberty | Missouri | 64068 | United States |
|
| Lake Regional Hospital | Recruiting | Osage Beach | Missouri | 65065 | United States |
|
| Mercy Hospital Springfield | Recruiting | Springfield | Missouri | 65804 | United States |
|
| CoxHealth South Hospital | Recruiting | Springfield | Missouri | 65807 | United States |
|
| Mercy Hospital South | Recruiting | St Louis | Missouri | 63128 | United States |
|
| Mercy Hospital Saint Louis | Recruiting | St Louis | Missouri | 63141 | United States |
|
| FirstHealth of the Carolinas-Moore Regional Hospital | Recruiting | Pinehurst | North Carolina | 28374 | United States |
|
| Wake Forest NCORP Research Base | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Good Samaritan Hospital - Cincinnati | Recruiting | Cincinnati | Ohio | 45220 | United States |
|
| Dayton Veterans Affairs Medical Center | Recruiting | Dayton | Ohio | 45428 | United States |
|
| Mercy Hospital Oklahoma City | Recruiting | Oklahoma City | Oklahoma | 73120 | United States |
|
| Charleston Oncology North Charleston | Recruiting | Charleston | South Carolina | 29406 | United States |
|
| Prisma Health Greenville Memorial Hospital | Recruiting | Greenville | South Carolina | 29605 | United States |
|
| Marshfield Clinic-Chippewa Center | Recruiting | Chippewa Falls | Wisconsin | 54729 | United States |
|
| Saint Vincent Hospital Cancer Center Green Bay | Recruiting | Green Bay | Wisconsin | 54301 | United States |
|
| Saint Vincent Hospital Cancer Center at Saint Mary's | Recruiting | Green Bay | Wisconsin | 54303 | United States |
|
| Aspirus Regional Cancer Center | Recruiting | Wausau | Wisconsin | 54401 | United States |
|
| San Patricio Medflix | Recruiting | Guaynabo | 00968 | Puerto Rico |
|
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D014565 | Urogenital Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided