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Improving Resection Rates Among African Americans With NSCLC

8 maj 2020 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

248

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / 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).
Övrig: 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).
Experimentell: 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).
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Receipt of LDTCI
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Wake Forest University Health Sciences

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 april 2015

Primärt slutförande (Faktisk)

23 augusti 2019

Avslutad studie (Faktisk)

9 september 2019

Studieregistreringsdatum

Först inskickad

17 juni 2013

Först inskickad som uppfyllde QC-kriterierna

24 juni 2013

Första postat (Uppskatta)

25 juni 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 maj 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 maj 2020

Senast verifierad

1 mars 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00031268
  • REBAWF 01414 (Annan identifierare: NCI)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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