About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Educational Intervention
Other interventionReceive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual
Behavioral Intervention
Other interventionComplete mentorship intervention
Survey Administration
Other interventionAncillary studies
Interview
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Research self-efficacy (RSE)
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.
Secondary outcomes
National Cancer Institute Community Oncology Research Program (NCORP) engagement
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.
Change in research care team integration
Measured by the Assessment for Collaborative Environments (ACE)-15. Will follow the same analysis plan as for the primary outcome.
Practice-level NCORP and National Clinical Trials Network (NCTN) study activity
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.
Acceptability of COACH-APP intervention (COACH-APP arm only)
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.
Sponsors and contacts
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Wake Forest University Health Sciences
Lead sponsor
National Cancer Institute (NCI)
Collaborator