COACH-APP: education and mentorship to help advanced practice providers join community oncology clinical teams
Building Capacity Within the NCORP Network Through an Education and Mentorship Intervention for Advanced Practice Providers (COACH-APP)
This program will test whether focused education and structured mentorship helps nurse practitioners and physician assistants in community oncology feel more confident taking part in clinical research.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 97 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 31 sites (Newark, Delaware and 30 other locations) |
| Trial ID | NCT06904391 on ClinicalTrials.gov |
What this trial studies
This randomized intervention compares a combined education plus structured mentorship program (COACH-APP) to an education-only control for advanced practice providers (APPs) in NCORP community oncology practices. The primary outcome is change in research self-efficacy (RSE) from baseline to 12 months post-randomization. Secondary outcomes include NCORP engagement, APP ratings of research team integration (ACE-15), practice-level trial activity over 24 months, and qualitative measures of acceptability and feasibility among participants and mentors. APPs in the intervention receive focused training plus mentor support while control sites receive education materials and usual support.
Who should consider this trial
Good fit: Ideal participants are practicing nurse practitioners or physician assistants at NCORP-affiliated community oncology practices who are registered as non-physician investigators (NPIVR), can enroll their practice in OPEN, and can commit about two hours per month for 12 months.
Not a fit: Practices without research infrastructure, APPs not registered as NPIVR, or APPs unable to commit the required time or administrative enrollment steps are unlikely to benefit from the intervention.
Why it matters
Potential benefit: If successful, the program could increase APP involvement in clinical research at community sites, improving patient access to trials and potentially enhancing care delivered locally.
How similar studies have performed: Educational and mentorship programs have shown promise for improving clinician engagement in research in other settings, but targeted randomized evidence focused on APPs within NCORP community oncology is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Newark, Delaware and 30 other locations
- Helen F Graham Cancer Center — Newark, Delaware, United States (Recruiting)
- Queen's Medical Center — Honolulu, Hawaii, United States (Recruiting)
- University of Hawaii Cancer Center — Honolulu, Hawaii, United States (Recruiting)
- The Queen's Medical Center - West Oahu — ‘Ewa Beach, Hawaii, United States (Recruiting)
- Illinois Cancer Care-Bloomington — Bloomington, Illinois, United States (Recruiting)
- Illinois Cancer Care - Eureka — Eureka, Illinois, United States (Recruiting)
- Illinois CancerCare-Galesburg — Galesburg, Illinois, United States (Recruiting)
- Illinois CancerCare-Macomb — Macomb, Illinois, United States (Recruiting)
- SSM Health Good Samaritan — Mount Vernon, Illinois, United States (Recruiting)
- Illinois Cancer Care-Pekin — Pekin, Illinois, United States (Recruiting)
- Illinois CancerCare-Peoria — Peoria, Illinois, United States (Recruiting)
- Illinois Cancer Care - Washington — Washington, Illinois, United States (Recruiting)
- HaysMed — Hays, Kansas, United States (Recruiting)
- Harold Alfond Center for Cancer Care — Augusta, Maine, United States (Recruiting)
- MaineHealth Cancer Care and IV Therapy - Brunswick — Brunswick, Maine, United States (Recruiting)
- MaineHealth Maine Medical Center - Portland — Portland, Maine, United States (Recruiting)
- MaineHealth Maine Medical Center- Scarborough — Scarborough, Maine, United States (Recruiting)
- Maine Health Cancer Care and IV Therapy - South Portland — South Portland, Maine, United States (Recruiting)
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan, United States (Recruiting)
- Corewell Health Reed City Hospital — Reed City, Michigan, United States (Recruiting)
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan, United States (Recruiting)
- Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States (Recruiting)
- Baptist Memorial Hospital and Cancer Center-Golden Triangle — Columbus, Mississippi, United States (Recruiting)
- Wake Forest NCORP Research Base — Winston-Salem, North Carolina, United States (Recruiting)
- Prisma Health Cancer Institute - Faris — Greenville, South Carolina, United States (Recruiting)
- Prisma Health Cancer Institute - Eastside — Greenville, South Carolina, United States (Recruiting)
- Gibbs Cancer Center-Pelham — Greer, South Carolina, United States (Recruiting)
- Spartanburg Medical Center — Spartanburg, South Carolina, United States (Recruiting)
- Sanford Cancer Center Oncology Clinic — Sioux Falls, South Dakota, United States (Recruiting)
- Baptist Memorial Hospital and Cancer Center-Memphis — Memphis, Tennessee, United States (Recruiting)
- Saint Vincent Hospital Cancer Center at Saint Mary's — Green Bay, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Karen Craver
- Email: NCORP@wfusm.edu
- Phone: 336-716-0891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.