Recruiting

COACH-APPEducation & Mentorship of Advanced Practice Providers to Increase Community-based Research Within the NCORP Network, COACH-APP Trial

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06904391

Conditions

Other

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Educational Intervention

Behavioral Intervention

Survey Administration

Interview

Study Details

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.

Conditions

Other

Study ID

NCT06904391

Start date

Sep 5, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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
MENTOR: Must have the following criteria:

Clinical practice experience in a practice that enrolls to NCORP and/or NCTN trials.
Participation in a leadership role within NCTN or NCORP (i.e., serving on a Research Base committee, working group, taskforce or as a site PI)
Willing to complete COACH-APP mentor training.
Willing to complete a 30-minute recorded phone interview about their experience with the COACH-APP intervention
RESEARCH CARE TEAM INTERVIEW: Must be an identified member of the Research Care Team for an APP assigned to the COACH-APP intervention arm. The Research Care Team will be reviewed by the APP in the 12 month survey for any changes
RESEARCH CARE TEAM INTERVIEW: Willing to participate in a recorded phone interview (approximately 30 minutes) to assess their perceptions of the COACH-APP intervention, including feasibility, acceptability, and impact

Exclusion Criteria:

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

Study Design

Enrollment

97 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Arm I (COACH-APP)

APPs 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.

active comparator: Arm II (education control)

APPs receive access to the SWOG APP Clinical Research Workshop and The Advanced Practice Provider Clinical Trials Research Manual for 12 months.

other: Mentors

The seven COACH-APP Mentors who provide the mentorship in the COACH-APP arm will also be enrolled as participants in the study.

other: Research Care Team Members

20 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

Educational Intervention

Receive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual

Behavioral Intervention

Complete mentorship intervention

Survey Administration

Ancillary studies

Interview

Ancillary studies

Primary outcome measure

Research self-efficacy (RSE) [ Time Frame: From baseline to 12 months post-randomization ]

Central Contacts and Locations

Central contacts

Karen Craver

336-716-0891 NCORP@wfusm.edu

Locations

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

302-623-4450 lbarone@christianacare.org

Principal Investigator:

Gregory A Masters

Queen's Medical Center

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

808-545-8548

Principal Investigator:

Christa Braun-Inglis

University of Hawaii Cancer Center

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

808-586-2979

Principal Investigator:

Christa Braun-Inglis

The Queen's Medical Center - West Oahu

Recruiting

‘Ewa Beach, Hawaii, United States, 96706

Contacts

rohta@queens.org

Principal Investigator:

Christa Braun-Inglis

Illinois Cancer Care-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

309-243-3605 andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A Faller

Illinois Cancer Care - Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

309-243-3605 andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A Faller

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

309-243-3605 andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A Faller

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

309-243-3605 andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A Faller

SSM Health Good Samaritan

Recruiting

Mount Vernon, Illinois, United States, 62864

Contacts

618-899-1894 gayla.hall@ssmhealth.com

Principal Investigator:

Jay W Carlson

Illinois Cancer Care-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

309-243-3605 andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

309-243-3605 andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A Faller

Illinois Cancer Care - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

309-243-3605 andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A Faller

HaysMed

Recruiting

Hays, Kansas, United States, 67601

Contacts

785-623-5774

Principal Investigator:

Jamie Myers

Harold Alfond Center for Cancer Care

Recruiting

Augusta, Maine, United States, 04330

Contacts

207-626-4855

Principal Investigator:

Scot C Remick

MaineHealth Cancer Care and IV Therapy - Brunswick

Recruiting

Brunswick, Maine, United States, 04011

Contacts

207-396-8670 clinicalresearch@mainehealth.org

Principal Investigator:

Scot C Remick

MaineHealth Maine Medical Center - Portland

Recruiting

Portland, Maine, United States, 04102

Contacts

207-396-8670 clinicalresearch@mainehealth.org

Principal Investigator:

Scot C Remick

MaineHealth Maine Medical Center- Scarborough

Recruiting

Scarborough, Maine, United States, 04074

Contacts

207-396-8670 clinicalresearch@mainehealth.org

Principal Investigator:

Scot C Remick

Maine Health Cancer Care and IV Therapy - South Portland

Recruiting

South Portland, Maine, United States, 04106

Contacts

207-396-8670 clinicalresearch@mainehealth.org

Principal Investigator:

Scot C Remick

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

734-712-7251 MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Rose A Juhasz

Corewell Health Reed City Hospital

Recruiting

Reed City, Michigan, United States, 49677

Contacts

616-391-1230 crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y Butler

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

734-712-7251 MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Rose A Juhasz

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

218-333-5000 OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Recruiting

Columbus, Mississippi, United States, 39705

Contacts

901-226-1366 BCCclintrials@bmhcc.org

Principal Investigator:

Leanna R Fendley

Wake Forest NCORP Research Base

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Glenn Lesser, MD

336-716-0891 ncorp@wakehealth.edu

Karen Craver, MT

336-716-0891 ncorp@wakehealth.edu

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

864-522-4317 Kim.Williams3@prismahealth.org

Principal Investigator:

Matgthew F Hudson

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

864-522-4317 Kim.Williams3@prismahealth.org

Principal Investigator:

Matthew F Hudson

Gibbs Cancer Center-Pelham

Recruiting

Greer, South Carolina, United States, 29651

Contacts

864-560-6104 kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

Spartanburg Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

864-560-6104 kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

605-312-3320 OncologyClinicTrialsSF@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

901-226-1366 BCCclintrials@bmhcc.org

Principal Investigator:

Leanna R Fendley

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

920-433-8889 wi_research_admin@hshs.org

Principal Investigator:

Anthony J Jaslowski

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

Mentorship, education intervention, COACH-APP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-09.