Education & Mentorship of Advanced Practice Providers to Increase Community-based Research Within the NCORP Network, COACH-APP Trial
COACH-APP
Building Capacity Within the NCORP Network Through an Education and Mentorship Intervention for Advanced Practice Providers (COACH-APP)
3 other identifiers
interventional
97
1 country
31
Brief Summary
This clinical trial evaluates whether a mentorship and education intervention called COACH-APP works to improve advanced practice providers' (APPs) confidence in their ability to participate in clinical research (research self-efficacy). APPs are skilled clinicians who are routinely part of cancer care teams, but who may not routinely be part of the research care team at community oncology sites. The COACH-APP program provides focused education and structured mentorship to assist in meaningful integration to the research care team, which may increase research self-efficacy among APPs and ultimately improve patient care and access to clinical trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
Typical duration for not_applicable
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2025
CompletedFirst Posted
Study publicly available on registry
April 1, 2025
CompletedStudy Start
First participant enrolled
September 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 9, 2026
April 1, 2026
2.8 years
March 24, 2025
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Research self-efficacy (RSE)
RSE score is calculated as sum of the 22-items measured on a 5-point Likert scale. Will be compared between the COACH-APP intervention and education control arms using a two-sample t-test.
From baseline to 12 months post-randomization
Secondary Outcomes (12)
National Cancer Institute Community Oncology Research Program (NCORP) engagement
At 12 months post randomization
Change in research care team integration
From baseline to 12 months post randomization
Practice-level NCORP and National Clinical Trials Network (NCTN) study activity
Up to 24 months
Acceptability of COACH-APP intervention (COACH-APP arm only)
At 12 months
Feasibility of COACH-APP intervention (COACH-APP arm only)
At 12 months
- +7 more secondary outcomes
Study Arms (4)
Arm I (COACH-APP)
EXPERIMENTALAPPs complete the SWOG APP Clinical Research Workshop, consisting of 6 modules, over 2 hours and receive The Advanced Practice Provider Clinical Trials Research Manual. APPs also complete 5 mentoring sessions, over 15-60 minutes each, over 12 months.
Arm II (education control)
ACTIVE COMPARATORAPPs receive access to the SWOG APP Clinical Research Workshop and The Advanced Practice Provider Clinical Trials Research Manual for 12 months.
Mentors
OTHERThe seven COACH-APP Mentors who provide the mentorship in the COACH-APP arm will also be enrolled as participants in the study.
Research Care Team Members
OTHER20 Research Care Team Members will also be enrolled in the study to participate in qualitative interviews to assess their perceptions of the COACH-APP intervention.
Interventions
Receive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual
Eligibility Criteria
You may qualify if:
- APP PRACTICE: Must have one practicing APP who can dedicate approximately 2 hours/month to participate in the intervention and study activities over a 12-month period, supported by their direct supervisor via the APP Support Statement
- APP PRACTICE: Must attest to research infrastructure that can support APP trial enrollment, as declared on the APP Practice Attestation
- APP PRACTICE: Must have submitted the APP Practice Attestation within the Study Interest Survey
- APP PRACTICE: Must have received the required APP practice ID for Oncology Patient Enrollment Network (OPEN) enrollment in the Study Selection Email prior to enrollment
- APP PRACTICE: Must enroll eligible practice site(s) in OPEN within 14 days of receiving the Study Selection Email.
- APP: Practicing nurse practitioner (NP) or physician assistant (PA) registered as an active non-physician investigators (NPIVR) within the National Cancer Institute (NCI) Registration and Credential Repository (RCR)
- APP: Treats oncology patients at practice that is actively recruiting to NCORP and/or NCTN trials
- APP: Not planning to leave their clinical position within the APP practice (defined as one or more NCORP affiliate or sub-affiliate site\[s\] where the APP participating in the study sees patients and clinical research activities occur) in the next 12 months at enrollment
- APP: Willing to participate in a 30-minute recorded phone interview, if selected
- APP: Completed and submitted the APP Attestation within the Study Interest Survey
- APP: Completed and submitted an APP Support Statement from their direct supervisor approving participation in this study, within the Study Interest Survey
- APP: Identify and obtain signed Research Care (RC) Team Acknowledgements from two members (defined below) of their research care team to assist them in this study. The RC team for this study will consist of an oncologist and clinical research professional (i.e., clinical research coordinator, clinical research associate clinical research nurse, etc.) that the APP collaborated with over the past 6 months or could collaborate with in the future to enroll patients on NCORP and/or NCTN trials
- APP: Must have received the required APP practice ID for OPEN enrollment in the Study Selection Email
- APP: Must enroll consented APPs in OPEN within 14 days of receiving the Study Selection Email
- MENTOR: Must be a practicing APP chosen by the WF-2403 COACH-APP Study MPIs
- +7 more criteria
You may not qualify if:
- APP PRACTICE: APP practice has an APP serving as a COACH-APP intervention mentor
- APP PRACTICE: Another APP at the same APP practice is already enrolled in this study (i.e., only 1 APP is allowed per APP practice)
- APP PRACTICE: Affiliate/sub-affiliate site(s) within this APP practice are already enrolled or are intended to be enrolled in this study under another APP practice
- APP: Has already completed the SWOG APP workshop
- APP: Served as a site principal investigator (PI) for an NCORP or NCTN study at any time
- APP: Participated as a presenter for the SWOG APP workshop
- APP: Participated on the planning committee for The Advanced Practice Provider Clinical Trials Research Manual
- APP: Participated on the planning committee for the SWOG APP workshop
- APP: Past or current member of SWOG APP Task Force Committee
- APP: Past or current member of Eastern Cooperative Oncology Group- American College of Radiology Imaging Network (ECOG-ACRIN) APP Committee
- MENTOR: Must not work at NC002-Wake Forest University Health Sciences or its affiliate/subaffiliate sites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706, United States
Illinois Cancer Care-Bloomington
Bloomington, Illinois, 61704, United States
Illinois Cancer Care - Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864, United States
Illinois Cancer Care-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois Cancer Care - Washington
Washington, Illinois, 61571, United States
HaysMed
Hays, Kansas, 67601, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine, 04011, United States
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074, United States
Maine Health Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705, United States
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Glenn Lesser, MD
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2025
First Posted
April 1, 2025
Study Start
September 5, 2025
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication for a 2 year duration
- Access Criteria
- upon request to NCORP@wakehealth.edu
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.