Improving Resection Rates Among African Americans With NSCLC
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Delaware
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Lewes, Delaware, Stany Zjednoczone, 19958
- Beebe Healthcare Tunnell Cancer Center
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Georgia
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Savannah, Georgia, Stany Zjednoczone, 31405
- Saint Joseph's/Candler Hospital
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, Stany Zjednoczone, 70121
- Ochsner NCORP
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Michigan
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Royal Oak, Michigan, Stany Zjednoczone, 48073
- Beaumont Hospital - Royal Oak
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Minnesota
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Saint Louis Park, Minnesota, Stany Zjednoczone, 55426
- Metro-Minnesota NCORP
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89106
- Nevada Cancer Research Foundation
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North Carolina
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Winston-Salem, North Carolina, Stany Zjednoczone, 27127
- Wake Forest University Health Sciences
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19111
- Fox Chase
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Virginia
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Richmond, Virginia, Stany Zjednoczone, 23298
- Virginia Commonwealth University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny 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).
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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).
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Eksperymentalny: 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). |
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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Receipt of LDTCI
Ramy czasowe: 12 Months Post-Enrollment
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Receipt of lung-directed therapy with curative intent (LDTCI), Inquiry at time of follow-up survey, confirmed by medical record review
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12 Months Post-Enrollment
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review
Ramy czasowe: Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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• 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).
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Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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Time to LDTCI (For Pts. Who Received LDTCI Only) Confirmed by Medical Record Review
Ramy czasowe: Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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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
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Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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Satisfaction with Care Received, Patient Satisfaction(REF) (28 items)
Ramy czasowe: 6 Months Post-Enrollment
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Satisfaction with Care Received, Patient Satisfaction(REF) (28 items).
6 Months Post-Enrollment
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6 Months Post-Enrollment
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Time of Death, Follow-up Survey, Confirmed by Medical Record Review
Ramy czasowe: Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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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.
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Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Kathryn E Weaver, PhD, Wake Forest Universith Health Sciences
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB00031268
- REBAWF 01414 (Inny identyfikator: NCI)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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