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

April 8, 2026 updated by: Wake Forest University Health Sciences

Building Capacity Within the NCORP Network Through an Education and Mentorship Intervention for Advanced Practice Providers (COACH-APP)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To compare change in research self-efficacy (RSE) scores from baseline to end of study (12 months post-randomization) between APPs in the COACH-APP intervention compared to the education control.

SECONDARY OBJECTIVES:

I. To compare National Cancer Institute (NCI) Community Oncology Research Program (NCORP) engagement post-study (12-months) for APPs in the COACH-APP intervention compared to the education control.

II. To compare changes from baseline to post-study in APP ratings of research care team integration (Assessment for Collaborative Environments [ACE]-15) between the COACH-APP intervention and education control.

III. To compare practice-level NCORP and National Clinical Trial Network (NCTN) study activity as measured by total number of accruals (patient, non-patient, and organizational) and number of actively recruiting NCORP and NCTN studies over 24 months between practices with APPs receiving the COACH-APP intervention versus those in education control.

IV. Within the COACH-APP intervention group, to measure acceptability, feasibility, and appropriateness of the COACH-APP intervention for APPs and COACH-APP mentors to guide future implementation.

V. Within the COACH-APP intervention group, conduct semi-structured interviews with a sub-set of mentors, APPs, and other key research team members (collaborating oncologists and clinical research professionals) to assess:

  • Va. Perceptions of feasibility, acceptability, and appropriateness of the COACH-APP intervention;
  • Vb. Potential effects of the COACH-APP intervention on the research care team functioning and environment;
  • Vc. Potential effects of the COACH-APP intervention on patient care quality and access to clinical trials;
  • Vd. Practice-level barriers and facilitators of APP engagement in research activities.

Study Type

Interventional

Enrollment (Estimated)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A Masters
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Medical Center
        • Contact:
          • Phone Number: 808-545-8548
        • Principal Investigator:
          • Christa Braun-Inglis
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • University of Hawaii Cancer Center
        • Contact:
          • Phone Number: 808-586-2979
        • Principal Investigator:
          • Christa Braun-Inglis
      • ‘Ewa Beach, Hawaii, United States, 96706
        • Recruiting
        • The Queen's Medical Center - West Oahu
        • Contact:
        • Principal Investigator:
          • Christa Braun-Inglis
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois Cancer Care-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A Faller
      • Eureka, Illinois, United States, 61530
      • Galesburg, Illinois, United States, 61401
      • Macomb, Illinois, United States, 61455
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • SSM Health Good Samaritan
        • Principal Investigator:
          • Jay W Carlson
        • Contact:
      • Pekin, Illinois, United States, 61554
      • Peoria, Illinois, United States, 61615
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois Cancer Care - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A Faller
    • Kansas
      • Hays, Kansas, United States, 67601
        • Recruiting
        • HaysMed
        • Principal Investigator:
          • Jamie Myers
        • Contact:
          • Phone Number: 785-623-5774
    • Maine
      • Augusta, Maine, United States, 04330
        • Recruiting
        • Harold Alfond Center for Cancer Care
        • Contact:
          • Phone Number: 207-626-4855
        • Principal Investigator:
          • Scot C Remick
      • Brunswick, Maine, United States, 04011
        • Recruiting
        • MaineHealth Cancer Care and IV Therapy - Brunswick
        • Contact:
        • Principal Investigator:
          • Scot C Remick
      • Portland, Maine, United States, 04102
        • Recruiting
        • MaineHealth Maine Medical Center - Portland
        • Contact:
        • Principal Investigator:
          • Scot C Remick
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • MaineHealth Maine Medical Center- Scarborough
        • Contact:
        • Principal Investigator:
          • Scot C Remick
      • South Portland, Maine, United States, 04106
        • Recruiting
        • Maine Health Cancer Care and IV Therapy - South Portland
        • Contact:
        • Principal Investigator:
          • Scot C Remick
    • Michigan
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Rose A Juhasz
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Corewell Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y Butler
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Rose A Juhasz
    • Minnesota
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Contact:
        • Principal Investigator:
          • Leanna R Fendley
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest NCORP Research Base
        • Contact:
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Contact:
        • Principal Investigator:
          • Matgthew F Hudson
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Principal Investigator:
          • Matthew F Hudson
        • Contact:
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Contact:
        • Principal Investigator:
          • Leanna R Fendley
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Principal Investigator:
          • Anthony J Jaslowski
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Survey Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Educational Intervention
Receive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual
Other: Behavioral Intervention
Complete mentorship intervention
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: Survey Administration
Ancillary studies
Other: Educational Intervention
Receive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual
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: Survey Administration
Ancillary studies
Other: Interview
Ancillary studies
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.
Other: Interview
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Research self-efficacy (RSE)
Time Frame: From baseline to 12 months post-randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Cancer Institute Community Oncology Research Program (NCORP) engagement
Time Frame: At 12 months post randomization
Measured by the sum of 8-items measured on a 5-point Likert scale. Will be compared between the COACH-APP intervention and education control arms using linear regression.
At 12 months post randomization
Change in research care team integration
Time Frame: From baseline to 12 months post randomization
Measured by the Assessment for Collaborative Environments (ACE)-15. Will follow the same analysis plan as for the primary outcome.
From baseline to 12 months post randomization
Practice-level NCORP and National Clinical Trials Network (NCTN) study activity
Time Frame: Up to 24 months
Measured by total number of accruals (patient, non-patient, and organizational) and number of actively recruiting NCORP and NCTN studies. Will be compared between the COACH-APP intervention and education control arms using linear regression.
Up to 24 months
Acceptability of COACH-APP intervention (COACH-APP arm only)
Time Frame: At 12 months
As measured by Acceptability of Intervention Measure (AIM). Will be summarized for the APPs in the COACH-APP intervention arm using mean and standard deviation and by capturing the percent who agree or strongly agree with the items.
At 12 months
Feasibility of COACH-APP intervention (COACH-APP arm only)
Time Frame: At 12 months
As measured by Feasibility of Intervention Measure (FIM). Will be summarized for the APPs in the COACH-APP intervention arm using mean and standard deviation and by capturing the percent who agree or strongly agree with the items.
At 12 months
Appropriateness of COACH-APP intervention (COACH-APP arm only)
Time Frame: At 12 months
As measured by Intervention Appropriateness Measure (IAM). Will be summarized for the APPs in the COACH-APP intervention arm using mean and standard deviation and by capturing the percent who agree or strongly agree with the items.
At 12 months
Perceptions of feasibility of the COACH-APP intervention
Time Frame: Day 1 (At time of interview)
Measured via qualitative interview. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Day 1 (At time of interview)
Perceptions of acceptability of the COACH-APP intervention
Time Frame: Day 1 (At time of interview)
Measured via qualitative interview. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Day 1 (At time of interview)
Perceptions of appropriateness of the COACH-APP intervention
Time Frame: Day 1 (At time of interview)
Measured via qualitative interview. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Day 1 (At time of interview)
Potential effects of the COACH-APP intervention on the research care team functioning and environment
Time Frame: Day 1 (At time of interview)
Measured via qualitative interviews. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Day 1 (At time of interview)
Potential effects of the COACH-APP intervention on patient care quality and access to clinical trials
Time Frame: Day 1 (At time of interview)
Measured via qualitative interviews. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Day 1 (At time of interview)
Practice-level barriers and facilitators of APP engagement in research activities
Time Frame: Day 1 (At time of interview)
Measured via qualitative interviews. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Day 1 (At time of interview)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Glenn Lesser, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00129381
  • UG1CA189824 (U.S. NIH Grant/Contract)
  • NCI-2025-01059 (Other Identifier: NCI Trial Identifier)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

6 months after publication for a 2 year duration

IPD Sharing Access Criteria

upon request to NCORP@wakehealth.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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