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

Active:	Yes
Cancer Type:	Solid Tumor	NCT ID:	NCT06904391
Trial Phases:		Protocol IDs:	WF-2403 (primary) WF-2403 WF-2403 NCI-2025-01059
Eligibility:	18 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	Wake Forest NCORP Research Base
NCI Full Details:	http://clinicaltrials.gov/show/NCT06904391

Summary

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.

Objectives

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 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.

EXPLORATORY OBJECTIVES:
I. To compare additional practice-level NCORP and NCTN study activity (number of treating investigators and number of credit investigators over 12 and 24 months and total number of accruals and number of actively recruiting NCORP and NCTN studies over 12 months) between practices with APPs receiving the COACH-APP intervention versus those in education control.
II. To compare practice-level NCORP cancer control (CC) and cancer care delivery research (CCDR) study activity (number of actively recruiting NCORP studies, total number of accruals, number of treating investigators, and number of credit investigators) over 12 and 24 months between practices with APPs receiving the COACH-APP intervention versus those in education control.
III. To compare changes in NCORP CC and CCDR study accrual patient demographics (race, ethnicity, sex, residence in a medically underserved area) over 12 and 24 months between practices with APPs receiving the COACH-APP intervention versus those in education control.

OUTLINE: APPs are randomized to 1 of 2 arms.

ARM I: APPs complete the Southwest Oncology Group (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.

ARM II: APPs receive access to the SWOG APP Clinical Research Workshop and The Advanced Practice Provider Clinical Trials Research Manual for 12 months.

After completion of study intervention, participants are followed up at 24 months.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.