Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Improving Resection Rates Among African Americans With NSCLC

8. mai 2020 oppdatert av: Wake Forest University Health Sciences
This is a randomized, interventional trial in which the navigation is the intervention. Phase is not applicable. The study is a randomized trial to evaluate the impact of a nurse-led patient navigation intervention in improving rates of receipt of lung-directed therapy with curative intent (LDTCI) among African Americans with early stage lung cancer. Study sites are cluster-randomized to either the usual care study arm or the to the navigation intervention study arm. Randomization occurred at the level of the study site rather than at the level of individual participants. There are two arms.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The burden to participants will be minimized to enhance retention. Patients in the usual care arm receive the current "gold standard" of treatment. The patients in the intervention arm are assigned to a PN, who helps to reduce the barriers to care that could negatively impact the patients' receipt of LDTCI. The telephone-administered survey is administered to all study participants at baseline and at 3-, 6-, and 12-months post-enrollment. It takes approximately 30-40 minutes to administer. The telephone mode of survey administration was chosen to reduce the number of visits that would be required by each patient. Interviews are scheduled at the convenience of the study participants. To further reduce burden to the study participants, the interviewers offer breaks during the interview process. Patients in both arms undergo standard therapy visits. Patients in the navigation arm receive standard therapy visits plus the navigation intervention. Outside of the standard therapy visits, no additional clinic visits are required of the study participants.

Once informed consent has been obtained and the informed consent document is received, the SSC/PN will communicate to the MUSC HCC study staff the participant's contact information and that the participant is ready for baseline survey administration. All the study surveys will be administered by trained MUSC HCC study staff via telephone. A survey answer guide will be provided to the participant either in-person or via mail prior to administration of the baseline survey.

Studietype

Intervensjonell

Registrering (Faktiske)

248

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Delaware
      • Lewes, Delaware, Forente stater, 19958
        • Beebe Healthcare Tunnell Cancer Center
    • Georgia
      • Savannah, Georgia, Forente stater, 31405
        • Saint Joseph's/Candler Hospital
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Stroger Hospital of Cook County
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70121
        • Ochsner NCORP
    • Michigan
      • Royal Oak, Michigan, Forente stater, 48073
        • Beaumont Hospital - Royal Oak
    • Minnesota
      • Saint Louis Park, Minnesota, Forente stater, 55426
        • Metro-Minnesota NCORP
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Nevada Cancer Research Foundation
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27127
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19111
        • Fox Chase
    • Virginia
      • Richmond, Virginia, Forente stater, 23298
        • Virginia Commonwealth University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • AA race
  • Clinically suspicious or biopsy-proven, early stage NSCLC, and
  • Ages 21 years and older

Exclusion Criteria:

  • Previous history of lung cancer
  • Spread of newly diagnosed probably/proven lung cancer to other part of the body
  • Diagnosis of synchronous cancer other than non-melanoma skin cancer or lung cancer, and
  • Receipt of surgical resection or radiosurgery for lung cancer since diagnosis with probable/proven lung cancer

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Usual Care Arm
Participants who are assigned to the usual care arm may receive the following services: complete staging work-up (CT/PET scan and possible mediastinoscopy), surgical consultation with a general or cardiothoracic surgeon, cardiac clearance and/or pulmonary function testing (if deemed necessary by the evaluating surgeon), surgical resection (wedge resection, lobectomy, pneumonectomy, or radiosurgery, as indicated by the size and location of the tumor), and adjuvant therapy (radiotherapy and/or chemotherapy, as determined by the intraoperative findings and pathology results).
Annen: Usual Care
Usual care includes: complete staging work-up (CT/PET scan and possible mediastinoscopy), surgical consultation with a general or cardiothoracic surgeon, cardiac clearance and/or pulmonary function testing (if deemed necessary by the evaluating surgeon), surgical resection (wedge resection, lobectomy, pneumonectomy, or radiosurgery, as indicated by the size and location of the tumor), and adjuvant therapy (radiotherapy and/or chemotherapy, as determined by the intraoperative findings and pathology results).
Eksperimentell: Intervention Arm

The PN will provide each patient with a copy of the NCI's "What You Need to Know About Lung Cancer" booklet and encourage them to re-contact his/her primary care physician (or the physician who diagnosed their probable/proven NSCLC) to discuss treatment options.

The PNs will provide patients with their contact information and brief patients on their role. The PNs will navigate study participants for up to 4 months (16 weeks, 112 days) after NSCLC diagnosis, until the patient is deemed ineligible for LDTCI (i.e., lung resection or SBRT) by their physician(s), until receipt of LDTCI, or death (whichever comes first).

During the EPDPN intervention period, PNs will contact each intervention group participant by telephone (or in-person) on weekly basis (at minimum).
Annen: Intervention Arm
The proposed Intervention (EPDPN) will be administered by the PNs at the intervention sites on an outpatient basis. Several defining, fundamental characteristics of the PNs will ensure consistency of the intervention delivery across the various study sites.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Receipt of LDTCI
Tidsramme: 12 Months Post-Enrollment
Receipt of lung-directed therapy with curative intent (LDTCI), Inquiry at time of follow-up survey, confirmed by medical record review
12 Months Post-Enrollment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review
Tidsramme: Baseline, 3, 6, 9, and 12 Months Post-Enrollment
• Receipt of surgical and/or radiation oncology consultation (defined as outpatient or inpatient consultation with a general or cardiothoracic surgeon and/or radiation oncologist to discuss LDTCI for NSCLC within 4 months post-diagnosis of probable/proven, early stage NSCLC).
Baseline, 3, 6, 9, and 12 Months Post-Enrollment
Time to LDTCI (For Pts. Who Received LDTCI Only) Confirmed by Medical Record Review
Tidsramme: Baseline, 3, 6, 9, and 12 Months Post-Enrollment
Time to LDTCI (For Pts. Who Received LDTCI Only). Inquiry at Time of Follow-Up Survey, Confirmed by Medical Record Review. Baseline, 3, 6, 9, and 12 Months Post-Enrollment
Baseline, 3, 6, 9, and 12 Months Post-Enrollment
Satisfaction with Care Received, Patient Satisfaction(REF) (28 items)
Tidsramme: 6 Months Post-Enrollment
Satisfaction with Care Received, Patient Satisfaction(REF) (28 items). 6 Months Post-Enrollment
6 Months Post-Enrollment
Time of Death, Follow-up Survey, Confirmed by Medical Record Review
Tidsramme: Baseline, 3, 6, 9, and 12 Months Post-Enrollment
Time of Death. Inquiry at Time of Follow-Up Survey, Confirmed by Medical Record Review , inquiry of cancer registries at study sites, and inquiry of Social Security Death Index. Baseline, 3, 6, 9, and 12 Months Post-Enrollment.
Baseline, 3, 6, 9, and 12 Months Post-Enrollment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wake Forest University Health Sciences

Etterforskere

  • Hovedetterforsker: Kathryn E Weaver, PhD, Wake Forest Universith Health Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. april 2015

Primær fullføring (Faktiske)

23. august 2019

Studiet fullført (Faktiske)

9. september 2019

Datoer for studieregistrering

Først innsendt

17. juni 2013

Først innsendt som oppfylte QC-kriteriene

24. juni 2013

Først lagt ut (Anslag)

25. juni 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00031268
  • REBAWF 01414 (Annen identifikator: NCI)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Ikke-småcellet lungekreft (NSCLC)

Kliniske studier på Usual Care

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Sri Lanka

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere