Education & Mentorship of Advanced Practice Providers to Increase Community-based Research Within the NCORP Network, COACH-APP Trial
NCT ID: NCT06904391
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
97 participants
INTERVENTIONAL
2025-09-05
2028-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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
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.
Educational Intervention
Receive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual
Survey Administration
Ancillary studies
Mentors
The seven COACH-APP Mentors who provide the mentorship in the COACH-APP arm will also be enrolled as participants in the study.
Survey Administration
Ancillary studies
Interview
Ancillary studies
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.
Interview
Ancillary studies
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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: 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
* 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: 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
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Glenn Lesser, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, United States
Illinois Cancer Care-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Illinois Cancer Care-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois Cancer Care - Washington
Washington, Illinois, United States
MaineHealth Maine Medical Center - Portland
Portland, Maine, United States
Maine Health Cancer Care and IV Therapy - South Portland
South Portland, Maine, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Glenn Lesser, MD
Role: primary
Karen Craver, MT
Role: backup
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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NCI-2025-01059
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00129381
Identifier Type: -
Identifier Source: org_study_id