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Éducation et mentorat des fournisseurs de pratique avancée pour augmenter la recherche communautaire au sein du réseau NCORP, entraîneur-application (COACH-APP)

1 octobre 2026 mis à jour par: Wake Forest University Health Sciences

Renforcer la capacité du réseau NCORP grâce à une intervention d'éducation et de mentorat pour les fournisseurs de pratique avancée (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.

Aperçu de l'étude

Description détaillée

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 (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.

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.

Type d'étude

Interventionnel

Inscription (Estimé)

97

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Karen Craver
  • Numéro de téléphone: 336-716-0891
  • E-mail: NCORP@wfusm.edu

Lieux d'étude

    • Delaware
      • Newark, Delaware, États-Unis, 19713
        • Recrutement
        • Helen F Graham Cancer Center
        • Chercheur principal:
          • Gregory A Masters
        • Contact:
    • Georgia
      • Hinesville, Georgia, États-Unis, 31313
        • Recrutement
        • Liberty County Cancer Care
        • Contact:
        • Chercheur principal:
          • Leonard R Henry
      • Jesup, Georgia, États-Unis, 31545
        • Recrutement
        • Regional Cancer Care - Jesup
        • Contact:
        • Chercheur principal:
          • Leonard R Henry
      • Savannah, Georgia, États-Unis, 31405
        • Recrutement
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
        • Contact:
        • Chercheur principal:
          • Leonard R Henry
    • Hawaii
      • Honolulu, Hawaii, États-Unis, 96813
        • Recrutement
        • Queen's Medical Center
        • Contact:
          • Numéro de téléphone: 808-545-8548
        • Chercheur principal:
          • Christa Braun-Inglis
      • Honolulu, Hawaii, États-Unis, 96813
        • Recrutement
        • University of Hawaii Cancer Center
        • Contact:
          • Numéro de téléphone: 808-586-2979
        • Chercheur principal:
          • Christa Braun-Inglis
      • ‘Ewa Beach, Hawaii, États-Unis, 96706
        • Recrutement
        • The Queen's Medical Center - West Oahu
        • Contact:
        • Chercheur principal:
          • Christa Braun-Inglis
    • Illinois
      • Bloomington, Illinois, États-Unis, 61704
        • Recrutement
        • Illinois Cancer Care-Bloomington
        • Contact:
        • Chercheur principal:
          • Bryan A Faller
      • Chicago, Illinois, États-Unis, 60612
        • Recrutement
        • John H Stroger Jr Hospital of Cook County
        • Contact:
          • Numéro de téléphone: 312-864-5204
        • Chercheur principal:
          • Deimante M Tamkus
      • Eureka, Illinois, États-Unis, 61530
        • Recrutement
        • Illinois Cancer Care - Eureka
        • Contact:
        • Chercheur principal:
          • Bryan A Faller
      • Galesburg, Illinois, États-Unis, 61401
        • Recrutement
        • Illinois CancerCare-Galesburg
        • Contact:
        • Chercheur principal:
          • Bryan A Faller
      • Macomb, Illinois, États-Unis, 61455
        • Recrutement
        • Illinois CancerCare-Macomb
        • Contact:
        • Chercheur principal:
          • Bryan A Faller
      • Mount Vernon, Illinois, États-Unis, 62864
        • Recrutement
        • SSM Health Good Samaritan
        • Chercheur principal:
          • Jay W Carlson
        • Contact:
      • Pekin, Illinois, États-Unis, 61554
        • Recrutement
        • Illinois Cancer Care-Pekin
        • Contact:
        • Chercheur principal:
          • Bryan A Faller
      • Peoria, Illinois, États-Unis, 61615
        • Recrutement
        • Illinois CancerCare-Peoria
        • Contact:
        • Chercheur principal:
          • Bryan A Faller
      • Washington, Illinois, États-Unis, 61571
        • Recrutement
        • Illinois Cancer Care - Washington
        • Contact:
        • Chercheur principal:
          • Bryan A Faller
    • Kansas
      • Hays, Kansas, États-Unis, 67601
        • Recrutement
        • HaysMed
        • Chercheur principal:
          • Jamie Myers
        • Contact:
          • Numéro de téléphone: 785-623-5774
      • Overland Park, Kansas, États-Unis, 66210
        • Recrutement
        • University of Kansas Cancer Center-Overland Park
        • Contact:
        • Chercheur principal:
          • Jamie Myers
      • Westwood, Kansas, États-Unis, 66205
        • Recrutement
        • University of Kansas Hospital-Westwood Cancer Center
        • Contact:
        • Chercheur principal:
          • Jamie Myers
    • Maine
      • Augusta, Maine, États-Unis, 04330
        • Recrutement
        • Harold Alfond Center for Cancer Care
        • Contact:
          • Numéro de téléphone: 207-626-4855
        • Chercheur principal:
          • Scot C Remick
      • Brunswick, Maine, États-Unis, 04011
        • Recrutement
        • MaineHealth Cancer Care and IV Therapy - Brunswick
        • Contact:
        • Chercheur principal:
          • Scot C Remick
      • Portland, Maine, États-Unis, 04102
        • Recrutement
        • MaineHealth Maine Medical Center - Portland
        • Contact:
        • Chercheur principal:
          • Scot C Remick
      • Scarborough, Maine, États-Unis, 04074
        • Recrutement
        • MaineHealth Maine Medical Center- Scarborough
        • Contact:
        • Chercheur principal:
          • Scot C Remick
      • South Portland, Maine, États-Unis, 04106
        • Recrutement
        • Maine Health Cancer Care and IV Therapy - South Portland
        • Contact:
        • Chercheur principal:
          • Scot C Remick
    • Michigan
      • Chelsea, Michigan, États-Unis, 48118
        • Recrutement
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Chercheur principal:
          • Rose A Juhasz
      • Reed City, Michigan, États-Unis, 49677
        • Recrutement
        • Corewell Health Reed City Hospital
        • Contact:
        • Chercheur principal:
          • Kathleen Y Butler
      • Ypsilanti, Michigan, États-Unis, 48197
        • Recrutement
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Chercheur principal:
          • Rose A Juhasz
    • Minnesota
    • Mississippi
      • Columbus, Mississippi, États-Unis, 39705
        • Recrutement
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Contact:
        • Chercheur principal:
          • Leanna R Fendley
    • Missouri
      • Joplin, Missouri, États-Unis, 64804
        • Recrutement
        • Mercy Hospital Joplin
        • Chercheur principal:
          • Jay W Carlson
        • Contact:
      • Kansas City, Missouri, États-Unis, 64154
        • Recrutement
        • University of Kansas Cancer Center - North
        • Contact:
        • Chercheur principal:
          • Jamie Myers
      • Kansas City, Missouri, États-Unis, 64116
        • Recrutement
        • University of Kansas Cancer Center - Briarcliff
        • Chercheur principal:
          • Jamie Myers
        • Contact:
          • Numéro de téléphone: 913-588-3671
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87109
        • Recrutement
        • Lovelace Women's Hospital
        • Contact:
        • Chercheur principal:
          • Bernard Tawfik
      • Albuquerque, New Mexico, États-Unis, 87102
    • North Carolina
      • Winston-Salem, North Carolina, États-Unis, 27157
        • Recrutement
        • Wake Forest NCORP Research Base
        • Contact:
        • Contact:
    • Pennsylvania
      • Lewistown, Pennsylvania, États-Unis, 17044
        • Recrutement
        • Lewistown Hospital
        • Chercheur principal:
          • Christian S Adonizio
        • Contact:
    • South Carolina
      • Greenville, South Carolina, États-Unis, 29605
        • Recrutement
        • Prisma Health Cancer Institute - Faris
        • Contact:
        • Chercheur principal:
          • Matgthew F Hudson
      • Greenville, South Carolina, États-Unis, 29615
        • Recrutement
        • Prisma Health Cancer Institute - Eastside
        • Chercheur principal:
          • Matthew F Hudson
        • Contact:
      • Greer, South Carolina, États-Unis, 29651
        • Recrutement
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Chercheur principal:
          • Michael Humeniuk
      • Spartanburg, South Carolina, États-Unis, 29303
        • Recrutement
        • Spartanburg Medical Center
        • Contact:
        • Chercheur principal:
          • Michael Humeniuk
    • South Dakota
      • Sioux Falls, South Dakota, États-Unis, 57104
    • Tennessee
      • Memphis, Tennessee, États-Unis, 38120
        • Recrutement
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Contact:
        • Chercheur principal:
          • Leanna R Fendley
    • Virginia
      • Richmond, Virginia, États-Unis, 23298
        • Recrutement
        • VCU Massey Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Mary H Hackney
    • Wisconsin
      • Green Bay, Wisconsin, États-Unis, 54303
        • Recrutement
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Chercheur principal:
          • Anthony J Jaslowski
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Ancillary studies

Ancillary studies

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

Complete mentorship intervention

Comparateur actif: 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.

Ancillary studies

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

Autre: Mentors

The seven COACH-APP Mentors who provide the mentorship in the COACH-APP arm will also be enrolled as participants in the study.

Ancillary studies

Ancillary studies

Autre: 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.

Ancillary studies

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Research self-efficacy (RSE)
Délai: 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.

From baseline to 12 months post-randomization

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
National Cancer Institute Community Oncology Research Program (NCORP) engagement
Délai: At 12 months post randomization

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.

At 12 months post randomization
Change in research care team integration
Délai: From baseline to 12 months post randomization

Measured by the Assessment for Collaborative Environments (ACE)-15. Will follow the same analysis plan as for the primary outcome.

From baseline to 12 months post randomization
Practice-level NCORP and National Clinical Trials Network (NCTN) study activity
Délai: Up to 24 months

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.

Up to 24 months
Acceptability of COACH-APP intervention (COACH-APP arm only)
Délai: At 12 months

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.

At 12 months
Feasibility of COACH-APP intervention (COACH-APP arm only)
Délai: At 12 months

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.

At 12 months
Appropriateness of COACH-APP intervention (COACH-APP arm only)
Délai: At 12 months

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.

At 12 months
Perceptions of feasibility of the COACH-APP intervention
Délai: Day 1 (At time of interview)

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.

Day 1 (At time of interview)
Perceptions of acceptability of the COACH-APP intervention
Délai: Day 1 (At time of interview)

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.

Day 1 (At time of interview)
Perceptions of appropriateness of the COACH-APP intervention
Délai: Day 1 (At time of interview)

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.

Day 1 (At time of interview)
Potential effects of the COACH-APP intervention on the research care team functioning and environment
Délai: Day 1 (At time of interview)

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.

Day 1 (At time of interview)
Potential effects of the COACH-APP intervention on patient care quality and access to clinical trials
Délai: Day 1 (At time of interview)

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.

Day 1 (At time of interview)
Practice-level barriers and facilitators of APP engagement in research activities
Délai: Day 1 (At time of interview)

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.

Day 1 (At time of interview)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Glenn Lesser, MD, Wake Forest University Health Sciences

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 septembre 2025

Achèvement primaire (Estimé)

30 juin 2028

Achèvement de l'étude (Estimé)

30 juin 2028

Dates d'inscription aux études

Première soumission

24 mars 2025

Première soumission répondant aux critères de contrôle qualité

31 mars 2025

Première publication (Réel)

1 avril 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

6 months after publication for a 2 year duration

Critères d'accès au partage IPD

upon request to NCORP@wakehealth.edu

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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