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NCORP 네트워크, Coach-App Trial 내에서 커뮤니티 기반 연구를 늘리기위한 고급 실무 제공 업체의 교육 및 멘토링 (COACH-APP)

2026년 10월 1일 업데이트: Wake Forest University Health Sciences

고급 실무 제공 업체를위한 교육 및 멘토링 개입을 통해 NCORP 네트워크 내에서의 수용 인력 (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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

97

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Karen Craver
  • 전화번호: 336-716-0891
  • 이메일: NCORP@wfusm.edu

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: Survey Administration

Ancillary studies

다른: Interview

Ancillary studies

다른: Educational Intervention

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

다른: Behavioral Intervention

Complete mentorship intervention
활성 비교기: 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.
다른: Survey Administration

Ancillary studies

다른: Educational Intervention

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

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

Ancillary studies

다른: Interview

Ancillary studies
다른: 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.
다른: Interview

Ancillary studies

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Research self-efficacy (RSE)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
National Cancer Institute Community Oncology Research Program (NCORP) engagement
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Wake Forest University Health Sciences

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Glenn Lesser, MD, Wake Forest University Health Sciences

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 9월 5일

기본 완료 (추정된)

2028년 6월 30일

연구 완료 (추정된)

2028년 6월 30일

연구 등록 날짜

최초 제출

2025년 3월 24일

QC 기준을 충족하는 최초 제출

2025년 3월 31일

처음 게시됨 (실제)

2025년 4월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 1일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB00129381
  • UG1CA189824 (미국 NIH 보조금/계약)
  • NCI-2025-01059 (기타 식별자: NCI Trial Identifier)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

6 months after publication for a 2 year duration

IPD 공유 액세스 기준

upon request to NCORP@wakehealth.edu

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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