Improving Resection Rates Among African Americans With NSCLC
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Delaware
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Lewes, Delaware, Соединенные Штаты, 19958
- Beebe Healthcare Tunnell Cancer Center
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Georgia
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Savannah, Georgia, Соединенные Штаты, 31405
- Saint Joseph's/Candler Hospital
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, Соединенные Штаты, 70121
- Ochsner NCORP
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Michigan
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Royal Oak, Michigan, Соединенные Штаты, 48073
- Beaumont Hospital - Royal Oak
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Minnesota
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Saint Louis Park, Minnesota, Соединенные Штаты, 55426
- Metro-Minnesota NCORP
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Nevada
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Las Vegas, Nevada, Соединенные Штаты, 89106
- Nevada Cancer Research Foundation
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North Carolina
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Winston-Salem, North Carolina, Соединенные Штаты, 27127
- Wake Forest University Health Sciences
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19111
- Fox Chase
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Virginia
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Richmond, Virginia, Соединенные Штаты, 23298
- Virginia Commonwealth University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Receipt of LDTCI
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Следователи
- Главный следователь: Kathryn E Weaver, PhD, Wake Forest Universith Health Sciences
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB00031268
- REBAWF 01414 (Другой идентификатор: NCI)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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