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

ConditionOther
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Educational Intervention

    Other intervention

    Receive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual

  • Behavioral Intervention

    Other intervention

    Complete mentorship intervention

  • Survey Administration

    Other intervention

    Ancillary studies

  • Interview

    Other intervention

    Ancillary studies

Treatment groups

97 Participants
are divided into 4 treatment groups
Group A: Arm I (COACH-APP)Experimental treatment 4 interventions
Group B: Arm II (education control)Active comparator 2 interventions
Group C: MentorsOther 2 interventions
Group D: Research Care Team MembersOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From baseline to 12 months post-randomization

Secondary outcomes

1

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.

Time frame
At 12 months post randomization
2

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.

Time frame
From baseline to 12 months post randomization
3

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.

Time frame
Up to 24 months
4

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.

Time frame
At 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Cancer Institute (NCI)

Collaborator