RECRUITING

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

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Conditions

OtherMentorship, education intervention, COACH-APP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-05
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06904391

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * APP PRACTICE: Must attest to research infrastructure that can support APP trial enrollment, as declared on the APP Practice Attestation
  3. * APP PRACTICE: Must have submitted the APP Practice Attestation within the Study Interest Survey
  4. * 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
  5. * 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)
  6. * APP: Treats oncology patients at practice that is actively recruiting to NCORP and/or NCTN trials
  7. * 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
  8. * APP: Willing to participate in a 30-minute recorded phone interview, if selected
  9. * APP: Completed and submitted the APP Attestation within the Study Interest Survey
  10. * APP: Completed and submitted an APP Support Statement from their direct supervisor approving participation in this study, within the Study Interest Survey
  11. * 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
  12. * APP: Must have received the required APP practice ID for OPEN enrollment in the Study Selection Email
  13. * MENTOR: Must be a practicing APP chosen by the WF-2403 COACH-APP Study MPIs
  14. * MENTOR: Must have the following criteria:
  15. * Clinical practice experience in a practice that enrolls to NCORP and/or NCTN trials.
  16. * 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)
  17. * Willing to complete COACH-APP mentor training.
  18. * Willing to complete a 30-minute recorded phone interview about their experience with the COACH-APP intervention
  19. * 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
  20. * 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
  1. * APP PRACTICE: APP practice has an APP serving as a COACH-APP intervention mentor
  2. * 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)
  3. * 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
  4. * APP: Has already completed the SWOG APP workshop
  5. * APP: Served as a site principal investigator (PI) for an NCORP or NCTN study at any time
  6. * APP: Participated as a presenter for the SWOG APP workshop
  7. * APP: Participated on the planning committee for The Advanced Practice Provider Clinical Trials Research Manual
  8. * APP: Participated on the planning committee for the SWOG APP workshop
  9. * APP: Past or current member of SWOG APP Task Force Committee
  10. * APP: Past or current member of Eastern Cooperative Oncology Group- American College of Radiology Imaging Network (ECOG-ACRIN) APP Committee
  11. * MENTOR: Must not work at NC002-Wake Forest University Health Sciences or its affiliate/subaffiliate sites

Contacts and Locations

Study Contact

Karen Craver
CONTACT
336-716-0891
NCORP@wakehealth.edu

Principal Investigator

Glenn Lesser, MD
STUDY_CHAIR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Glenn Lesser, MD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2025-09-05
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-09-05
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

  • Mentorship, education intervention, COACH-APP

Additional Relevant MeSH Terms

  • Other