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Educación y tutoría de proveedores de práctica avanzada para aumentar la investigación basada en la comunidad dentro de la red NCorp, ensayo de entrenador (COACH-APP)

1 de octubre de 2026 actualizado por: Wake Forest University Health Sciences

Capacidad de construcción dentro de la red NCORP a través de una intervención de educación y tutoría para proveedores de práctica avanzada (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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

97

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Karen Craver
  • Número de teléfono: 336-716-0891
  • Correo electrónico: NCORP@wfusm.edu

Ubicaciones de estudio

  • Estados Unidos
    • Delaware
      • Newark, Delaware, Estados Unidos, 19713
        • Reclutamiento
        • Helen F Graham Cancer Center
        • Investigador principal:
          • Gregory A Masters
        • Contacto:
    • Georgia
      • Hinesville, Georgia, Estados Unidos, 31313
        • Reclutamiento
        • Liberty County Cancer Care
        • Contacto:
        • Investigador principal:
          • Leonard R Henry
      • Jesup, Georgia, Estados Unidos, 31545
        • Reclutamiento
        • Regional Cancer Care - Jesup
        • Contacto:
        • Investigador principal:
          • Leonard R Henry
      • Savannah, Georgia, Estados Unidos, 31405
        • Reclutamiento
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
        • Contacto:
        • Investigador principal:
          • Leonard R Henry
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Reclutamiento
        • Queen's Medical Center
        • Contacto:
          • Número de teléfono: 808-545-8548
        • Investigador principal:
          • Christa Braun-Inglis
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Reclutamiento
        • University of Hawaii Cancer Center
        • Contacto:
          • Número de teléfono: 808-586-2979
        • Investigador principal:
          • Christa Braun-Inglis
      • ‘Ewa Beach, Hawaii, Estados Unidos, 96706
        • Reclutamiento
        • The Queen's Medical Center - West Oahu
        • Contacto:
        • Investigador principal:
          • Christa Braun-Inglis
    • Illinois
      • Bloomington, Illinois, Estados Unidos, 61704
        • Reclutamiento
        • Illinois Cancer Care-Bloomington
        • Contacto:
        • Investigador principal:
          • Bryan A Faller
      • Chicago, Illinois, Estados Unidos, 60612
        • Reclutamiento
        • John H Stroger Jr Hospital of Cook County
        • Contacto:
          • Número de teléfono: 312-864-5204
        • Investigador principal:
          • Deimante M Tamkus
      • Eureka, Illinois, Estados Unidos, 61530
        • Reclutamiento
        • Illinois Cancer Care - Eureka
        • Contacto:
        • Investigador principal:
          • Bryan A Faller
      • Galesburg, Illinois, Estados Unidos, 61401
        • Reclutamiento
        • Illinois CancerCare-Galesburg
        • Contacto:
        • Investigador principal:
          • Bryan A Faller
      • Macomb, Illinois, Estados Unidos, 61455
        • Reclutamiento
        • Illinois CancerCare-Macomb
        • Contacto:
        • Investigador principal:
          • Bryan A Faller
      • Mount Vernon, Illinois, Estados Unidos, 62864
        • Reclutamiento
        • SSM Health Good Samaritan
        • Investigador principal:
          • Jay W Carlson
        • Contacto:
      • Pekin, Illinois, Estados Unidos, 61554
        • Reclutamiento
        • Illinois Cancer Care-Pekin
        • Contacto:
        • Investigador principal:
          • Bryan A Faller
      • Peoria, Illinois, Estados Unidos, 61615
        • Reclutamiento
        • Illinois CancerCare-Peoria
        • Contacto:
        • Investigador principal:
          • Bryan A Faller
      • Washington, Illinois, Estados Unidos, 61571
        • Reclutamiento
        • Illinois Cancer Care - Washington
        • Contacto:
        • Investigador principal:
          • Bryan A Faller
    • Kansas
      • Hays, Kansas, Estados Unidos, 67601
        • Reclutamiento
        • HaysMed
        • Investigador principal:
          • Jamie Myers
        • Contacto:
          • Número de teléfono: 785-623-5774
      • Overland Park, Kansas, Estados Unidos, 66210
        • Reclutamiento
        • University of Kansas Cancer Center-Overland Park
        • Contacto:
        • Investigador principal:
          • Jamie Myers
      • Westwood, Kansas, Estados Unidos, 66205
        • Reclutamiento
        • University of Kansas Hospital-Westwood Cancer Center
        • Contacto:
        • Investigador principal:
          • Jamie Myers
    • Maine
      • Augusta, Maine, Estados Unidos, 04330
        • Reclutamiento
        • Harold Alfond Center for Cancer Care
        • Contacto:
          • Número de teléfono: 207-626-4855
        • Investigador principal:
          • Scot C Remick
      • Brunswick, Maine, Estados Unidos, 04011
        • Reclutamiento
        • MaineHealth Cancer Care and IV Therapy - Brunswick
        • Contacto:
        • Investigador principal:
          • Scot C Remick
      • Portland, Maine, Estados Unidos, 04102
        • Reclutamiento
        • MaineHealth Maine Medical Center - Portland
        • Contacto:
        • Investigador principal:
          • Scot C Remick
      • Scarborough, Maine, Estados Unidos, 04074
        • Reclutamiento
        • MaineHealth Maine Medical Center- Scarborough
        • Contacto:
        • Investigador principal:
          • Scot C Remick
      • South Portland, Maine, Estados Unidos, 04106
        • Reclutamiento
        • Maine Health Cancer Care and IV Therapy - South Portland
        • Contacto:
        • Investigador principal:
          • Scot C Remick
    • Michigan
      • Chelsea, Michigan, Estados Unidos, 48118
        • Reclutamiento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contacto:
        • Investigador principal:
          • Rose A Juhasz
      • Reed City, Michigan, Estados Unidos, 49677
        • Reclutamiento
        • Corewell Health Reed City Hospital
        • Contacto:
        • Investigador principal:
          • Kathleen Y Butler
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Reclutamiento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contacto:
        • Investigador principal:
          • Rose A Juhasz
    • Minnesota
      • Bemidji, Minnesota, Estados Unidos, 56601
    • Mississippi
      • Columbus, Mississippi, Estados Unidos, 39705
        • Reclutamiento
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Contacto:
        • Investigador principal:
          • Leanna R Fendley
    • Missouri
      • Joplin, Missouri, Estados Unidos, 64804
        • Reclutamiento
        • Mercy Hospital Joplin
        • Investigador principal:
          • Jay W Carlson
        • Contacto:
      • Kansas City, Missouri, Estados Unidos, 64154
        • Reclutamiento
        • University of Kansas Cancer Center - North
        • Contacto:
        • Investigador principal:
          • Jamie Myers
      • Kansas City, Missouri, Estados Unidos, 64116
        • Reclutamiento
        • University of Kansas Cancer Center - Briarcliff
        • Investigador principal:
          • Jamie Myers
        • Contacto:
          • Número de teléfono: 913-588-3671
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87109
        • Reclutamiento
        • Lovelace Women's Hospital
        • Contacto:
        • Investigador principal:
          • Bernard Tawfik
      • Albuquerque, New Mexico, Estados Unidos, 87102
        • Reclutamiento
        • Lovelace Women's Hospital
        • Investigador principal:
          • Bernard Tawfik
        • Contacto:
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Reclutamiento
        • Wake Forest NCORP Research Base
        • Contacto:
        • Contacto:
    • Pennsylvania
      • Lewistown, Pennsylvania, Estados Unidos, 17044
        • Reclutamiento
        • Lewistown Hospital
        • Investigador principal:
          • Christian S Adonizio
        • Contacto:
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29605
        • Reclutamiento
        • Prisma Health Cancer Institute - Faris
        • Contacto:
        • Investigador principal:
          • Matgthew F Hudson
      • Greenville, South Carolina, Estados Unidos, 29615
        • Reclutamiento
        • Prisma Health Cancer Institute - Eastside
        • Investigador principal:
          • Matthew F Hudson
        • Contacto:
      • Greer, South Carolina, Estados Unidos, 29651
        • Reclutamiento
        • Gibbs Cancer Center-Pelham
        • Contacto:
        • Investigador principal:
          • Michael Humeniuk
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • Reclutamiento
        • Spartanburg Medical Center
        • Contacto:
        • Investigador principal:
          • Michael Humeniuk
    • South Dakota
      • Sioux Falls, South Dakota, Estados Unidos, 57104
        • Reclutamiento
        • Sanford Cancer Center Oncology Clinic
        • Contacto:
        • Investigador principal:
          • Daniel Almquist
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38120
        • Reclutamiento
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Contacto:
        • Investigador principal:
          • Leanna R Fendley
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23298
        • Reclutamiento
        • VCU Massey Comprehensive Cancer Center
        • Contacto:
        • Investigador principal:
          • Mary H Hackney
    • Wisconsin
      • Green Bay, Wisconsin, Estados Unidos, 54303
        • Reclutamiento
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Investigador principal:
          • Anthony J Jaslowski
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: Survey Administration

Ancillary studies

Otro: Interview

Ancillary studies

Otro: Educational Intervention

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

Otro: Behavioral Intervention

Complete mentorship intervention
Comparador activo: 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.
Otro: Survey Administration

Ancillary studies

Otro: Educational Intervention

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

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

Ancillary studies

Otro: Interview

Ancillary studies
Otro: 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.
Otro: Interview

Ancillary studies

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Research self-efficacy (RSE)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
National Cancer Institute Community Oncology Research Program (NCORP) engagement
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Wake Forest University Health Sciences

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Silla de estudio: Glenn Lesser, MD, Wake Forest University Health Sciences

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de septiembre de 2025

Finalización primaria (Estimado)

30 de junio de 2028

Finalización del estudio (Estimado)

30 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

24 de marzo de 2025

Primero enviado que cumplió con los criterios de control de calidad

31 de marzo de 2025

Publicado por primera vez (Actual)

1 de abril de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB00129381
  • UG1CA189824 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2025-01059 (Otro identificador: NCI Trial Identifier)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir IPD

6 months after publication for a 2 year duration

Criterios de acceso compartido de IPD

upon request to NCORP@wakehealth.edu

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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