Dysautonomia International

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

Purpose

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.

Condition

Other

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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: 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 Other: Survey Administration Ancillary studies Other: Interview Ancillary studies
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: Educational Intervention Receive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual Other: Survey Administration Ancillary studies
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

Recruiting Locations

Helen F Graham Cancer Center
Newark, Delaware 19713

Contact:
302-623-4450
lbarone@christianacare.org

Queen's Medical Center
Honolulu, Hawaii 96813

Contact:
808-545-8548

University of Hawaii Cancer Center
Honolulu, Hawaii 96813

Contact:
808-586-2979

The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii 96706

Contact:
rohta@queens.org

Illinois Cancer Care-Bloomington
Bloomington, Illinois 61704