OtherCOACH-APPNCT06904391
Education & Mentorship of Advanced Practice Providers to Increase Community-based Research Within the NCORP Network, COACH-APP Trial
A study testing Educational Intervention, Behavioral Intervention and Survey Administration in people with Other, run by Wake Forest University Health Sciences at 44 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Other
- What is being tested?
- Educational Intervention, Behavioral Intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 44 sitesUnited States
- Study dates
- 5 Sep 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
44 sites in 1 country. Contact the study team or a site near you to ask about taking part.
44 sites in 1 country
United States44 sites, 44 recruiting
- Recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
rohta@queens.org
Christa Braun-Inglis
- Recruiting
Lovelace Women's Hospital
Albuquerque, New Mexico, 87102
505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Bernard Tawfik
- Recruiting
Lovelace Women's Hospital
Albuquerque, New Mexico, 87109
505-272-0530, AYost@nmcca.org
Bernard Tawfik
- Recruiting
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
207-626-4855
Scot C Remick
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Illinois Cancer Care-Bloomington
Bloomington, Illinois, 61704
309-243-3605, andersonj@illinoiscancercare.com
Bryan A Faller
- Recruiting
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine, 04011
207-396-8670, clinicalresearch@mainehealth.org
Scot C Remick
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Rose A Juhasz
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
312-864-5204
Deimante M Tamkus
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
901-226-1366, BCCclintrials@bmhcc.org
Leanna R Fendley
- Recruiting
Illinois Cancer Care - Eureka
Eureka, Illinois, 61530
309-243-3605, andersonj@illinoiscancercare.com
Bryan A Faller
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
309-243-3605, andersonj@illinoiscancercare.com
Bryan A Faller
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
920-433-8889, wi_research_admin@hshs.org
Anthony J Jaslowski
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
864-522-4317, Kim.Williams3@prismahealth.org
Matgthew F Hudson
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
864-522-4317, Kim.Williams3@prismahealth.org
Matthew F Hudson
- Recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
HaysMed
Hays, Kansas, 67601
785-623-5774
Jamie Myers
- Recruiting
Liberty County Cancer Care
Hinesville, Georgia, 31313
912-819-5704, Oncologyresearch@sjchs.org
Leonard R Henry
- Recruiting
Queen's Medical Center
Honolulu, Hawaii, 96813
808-545-8548
Christa Braun-Inglis
- Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
808-586-2979
Christa Braun-Inglis
- Recruiting
Regional Cancer Care - Jesup
Jesup, Georgia, 31545
912-819-5704, Oncologyresearch@sjchs.org
Leonard R Henry
- Recruiting
Mercy Hospital Joplin
Joplin, Missouri, 64804
417-556-3074, esmeralda.carrillo@mercy.net
Jay W Carlson
- Recruiting
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116
913-588-3671
Jamie Myers
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
913-588-3671, KUCC_Navigation@kumc.edu
Jamie Myers
- Recruiting
Lewistown Hospital
Lewistown, Pennsylvania, 17044
717-242-7703, cancerresearch@geisinger.edu
Christian S Adonizio
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
309-243-3605, andersonj@illinoiscancercare.com
Bryan A Faller
- Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
901-226-1366, BCCclintrials@bmhcc.org
Leanna R Fendley
- Recruiting
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
618-899-1894, gayla.hall@ssmhealth.com
Jay W Carlson
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
302-623-4450, lbarone@christianacare.org
Gregory A Masters
- Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
913-588-3671, KUCC_Navigation@kumc.edu
Jamie Myers
- Recruiting
Illinois Cancer Care-Pekin
Pekin, Illinois, 61554
309-243-3605, andersonj@illinoiscancercare.com
Bryan A Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
309-243-3605, andersonj@illinoiscancercare.com
Bryan A Faller
- Recruiting
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102
207-396-8670, clinicalresearch@mainehealth.org
Scot C Remick
- Recruiting
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y Butler
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
804-628-6430, CTOclinops@vcu.edu
Mary H Hackney
- Recruiting
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
912-819-5704, underberga@sjchs.org
Leonard R Henry
- Recruiting
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
207-396-8670, clinicalresearch@mainehealth.org
Scot C Remick
- Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
- Recruiting
Maine Health Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106
207-396-8670, clinicalresearch@mainehealth.org
Scot C Remick
- Recruiting
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Illinois Cancer Care - Washington
Washington, Illinois, 61571
309-243-3605, andersonj@illinoiscancercare.com
Bryan A Faller
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
913-588-3671, KUCC_Navigation@kumc.edu
Jamie Myers
- Recruiting
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157
Glenn Lesser, MD, 336-716-0891, ncorp@wakehealth.edu
Karen Craver, MT, 336-716-0891, ncorp@wakehealth.edu
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Rose A Juhasz
About this study
Official title: Building Capacity Within the NCORP Network Through an Education and Mentorship Intervention for Advanced Practice Providers (COACH-APP)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- To compare National Cancer Institute (NCI) 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.
- 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.
- Conditions
- Other
- Being tested
- Educational Intervention, Behavioral Intervention, Survey Administration, Interview
- Keywords
- Mentorship, education intervention, COACH-APP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Receive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual
Behavioral InterventionOther
Complete mentorship intervention
Survey AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (COACH-APP) | Experimental | 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. Receives: Other: Educational Intervention; Other: Behavioral Intervention; Other: Survey Administration; Other: Interview |
| Arm II (education control) | Active comparator | APPs receive access to the SWOG APP Clinical Research Workshop and The Advanced Practice Provider Clinical Trials Research Manual for 12 months. Receives: Other: Educational Intervention; Other: Survey Administration |
| Mentors | Other | The seven COACH-APP Mentors who provide the mentorship in the COACH-APP arm will also be enrolled as participants in the study. Receives: Other: Survey Administration; Other: Interview |
| Research Care Team Members | Other | 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. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 12 months post-randomization
Secondary outcomes (12)
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.
Measured: At 12 months post randomization
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.
Measured: From baseline to 12 months post randomization
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.
Measured: Up to 24 months
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.
Measured: At 12 months
Feasibility of COACH-APP intervention (COACH-APP arm only)
As measured by Feasibility of Intervention Measure (FIM). 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.
Measured: At 12 months
Appropriateness of COACH-APP intervention (COACH-APP arm only)
As measured by Intervention Appropriateness Measure (IAM). 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.
Measured: At 12 months
Perceptions of feasibility of the COACH-APP intervention
Measured via qualitative interview. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Measured: Day 1 (At time of interview)
Perceptions of acceptability of the COACH-APP intervention
Measured via qualitative interview. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Measured: Day 1 (At time of interview)
Perceptions of appropriateness of the COACH-APP intervention
Measured via qualitative interview. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Measured: Day 1 (At time of interview)
Potential effects of the COACH-APP intervention on the research care team functioning and environment
Measured via qualitative interviews. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Measured: Day 1 (At time of interview)
Potential effects of the COACH-APP intervention on patient care quality and access to clinical trials
Measured via qualitative interviews. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Measured: Day 1 (At time of interview)
Practice-level barriers and facilitators of APP engagement in research activities
Measured via qualitative interviews. Thematic analysis of the qualitative data will be used to summarize key themes from the APP, Mentor and RC Team semi-structured interview recordings and transcripts.
Measured: Day 1 (At time of interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start5 Sep 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtherStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Glenn Lesser, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904391
- Sponsor's protocol ID
- IRB00129381
- Other IDs
- NCI-2025-01059, UG1CA189824
- Acronym
- COACH-APP
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity Within the NCORP Network Through an Education and Mentorship Intervention for Advanced Practice Providers (COACH-APP)
- ClinicalTrials.gov ID
- NCT06904391
- Acronym / sponsor ID
- COACH-APP / IRB00129381
- Conditions
- Other
- Keywords
- Mentorship, education intervention, COACH-APP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- To compare National Cancer Institute (NCI) 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (COACH-APP) | Experimental | Other: Educational Intervention, Other: Behavioral Intervention, Other: Survey Administration, Other: InterviewAPPs 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. |
| Arm II (education control) | Active comparator | Other: Educational Intervention, Other: Survey AdministrationAPPs receive access to the SWOG APP Clinical Research Workshop and The Advanced Practice Provider Clinical Trials Research Manual for 12 months. |
| Mentors | Other | Other: Survey Administration, Other: InterviewThe seven COACH-APP Mentors who provide the mentorship in the COACH-APP arm will also be enrolled as participants in the study. |
| Research Care Team Members | Other | Other: Interview20 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionReceive access to SWOG APP Clinical Research workshop. Receive The Advanced Practice Provider Clinical Trials Research Manual | Other | Arm I (COACH-APP), Arm II (education control) |
| Behavioral InterventionComplete mentorship intervention | Other | Arm I (COACH-APP) |
| Survey AdministrationAncillary studies | Other | Arm I (COACH-APP), Arm II (education control), Mentors |
| InterviewAncillary studies | Other | Arm I (COACH-APP), Mentors, Research Care Team Members |
Primary outcome
Research self-efficacy (RSE)
Time frame: From baseline to 12 months post-randomization
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.
12 secondary outcomes
National Cancer Institute Community Oncology Research Program (NCORP) engagement
Time frame: At 12 months post randomization
Change in research care team integration
Time frame: From baseline to 12 months post randomization
Practice-level NCORP and National Clinical Trials Network (NCTN) study activity
Time frame: Up to 24 months
Acceptability of COACH-APP intervention (COACH-APP arm only)
Time frame: At 12 months
Feasibility of COACH-APP intervention (COACH-APP arm only)
Time frame: At 12 months
Appropriateness of COACH-APP intervention (COACH-APP arm only)
Time frame: At 12 months
Perceptions of feasibility of the COACH-APP intervention
Time frame: Day 1 (At time of interview)
Perceptions of acceptability of the COACH-APP intervention
Time frame: Day 1 (At time of interview)
Perceptions of appropriateness of the COACH-APP intervention
Time frame: Day 1 (At time of interview)
Potential effects of the COACH-APP intervention on the research care team functioning and environment
Time frame: Day 1 (At time of interview)
Potential effects of the COACH-APP intervention on patient care quality and access to clinical trials
Time frame: Day 1 (At time of interview)
Practice-level barriers and facilitators of APP engagement in research activities
Time frame: Day 1 (At time of interview)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Lesser, MD study chair
Wake Forest University Health Sciences
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Behavioral Intervention and Survey Administration in people with Other, run by Wake Forest University Health Sciences at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Craver (336-716-0891, NCORP@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research self-efficacy (RSE) (time frame: From baseline to 12 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.