- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02887521
Pulmonary Rehabilitation Before Lung Cancer Resection
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Prospectively, 194 patients will be randomized to either ten sessions of preoperative pulmonary rehabilitation (PR) vs. standard care at a number of healthcare centers throughout the United States. This study will be open for 36 months. Randomization will be stratified by three variables: very severe lung function (yes vs. no), prior neo-adjuvant chemotherapy for this operation (yes vs. no) and open thoracotomy vs. video assisted thoracoscopy. The primary and secondary objectives are provided below.
Primary Objective:
To prospectively determine the effect of 10 sessions of customized preoperative PR on the length of hospital stay in patients that undergo a lung cancer resection and have COPD compared to a matched control group. Hypothesis: Ten sessions of customized preoperative PR will significantly reduce the length of hospital stay.
Secondary Objectives:
To prospectively determine the effect of 10 sessions of customized preoperative PR on the number of postoperative complications in patients that undergo a lung cancer resection and have COPD compared to a matched control group.
- Hypothesis: Ten sessions of customized preoperative PR will significantly reduce the number of postoperative pulmonary complications.
To prospectively determine the effect of a 10-session preoperative PR on the trajectory of quality of life at 3 and 6 months after the curative resection compared to a matched control group.
- Hypothesis: Ten sessions of customized preoperative PR will significantly and meaningfully (more than the minimal clinically important difference) improve quality of life after surgery compared to a control group.
Patients will be followed at 3 and 6 months post-surgery.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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London, Ontario, Canadá, N6A 4L6
- London Regional Cancer Program
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-
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Florida
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Jacksonville, Florida, Estados Unidos, 32224-9980
- Mayo Clinic in Florida
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Baylor University Medical Center
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54301
- Saint Vincent Hospital Cancer Center Green Bay
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- Patient is scheduled to undergo NSCLC resection: video assisted thoracoscopy (VATS) or open thoracotomy for: limited resection, lobectomy, or pneumonectomy. Surgery must not be scheduled to take place < 3 weeks after registration.
- Patient has a doctor diagnosis of COPD.
- Patient is a current or ex-smoker with a smoking history of ≥ 10 pack years. (Calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. For example, 1 pack-year is equal to smoking 20 cigarettes (1 pack) per day for 1 year, or 40 cigarettes per day for half a year, and so on).
- Age ≥ 18 yrs
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Pulmonary Rehabilitation (PR)
Patients will receive 10 in-clinic sessions of preoperative Pulmonary Rehabilitation (PR) two weeks prior to surgery.
Patients will receive a Participant Manual demonstrating and explaining the rehabilitation process.
Patients will also receive a log for recording their efforts and notes for every day until the day of surgery.
A video recording of the intervention from start to finish will be provided to all patients.
The video recording should be played in all 10 sessions at the registering site.
The PR sessions will include breathing awareness, upper and lower extremity exercise, instructions for inspiratory muscle training using the PFlex valve, practice at home and goal setting.
Patients undergo surgery and will be followed until 6 months following surgery.
Patients complete follow up questionnaires at 3 and 6 months after discharge.
|
pulmonary rehabilitation participant manual
pulmonary rehabilitation
receive a pamphlet with exercises plus the standard course of care
patients undergo surgery
|
Comparador activo: Standard of Care
Patients will receive a pedometer to monitor their daily steps and a pamphlet with exercises plus the standard course of care for patients undergoing lung resection surgery.
The patients will not be asked to return the pedometer.
The local institutional coordinator will go over the use of the pedometer and the exercise materials with the patient.
The patients will be asked to keep a log of their pre-operative steps and mail the log to the registering site.
Patients undergo surgery and will be followed until 6 months following surgery.
Patients complete follow up questionnaires at 3 and 6 months after discharge.
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pulmonary rehabilitation participant manual
receive a pamphlet with exercises plus the standard course of care
patients undergo surgery
receive a pedometer
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Hospital Length of Stay Assessed With Complete Admission Hospital Records
Periodo de tiempo: Up to 6 months
|
The coordinator at each site will be responsible for sending complete de-identified hospital records from each patient to Dr. Benzo's staff, where a nurse blinded to the study arm will abstract the main outcome (length of stay and postoperative complications). The primary endpoint will be assessed at Dr. Benzo's office (Mayo Clinic) with the complete admission hospital records in order to extract the length of stay. The records will be mailed from the sites to Johanna Hoult in a pre-stamped envelope. |
Up to 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Post-operative Pulmonary Complications Assessed by Chart Review
Periodo de tiempo: Up to 6 months
|
The following events will be considered postoperative pulmonary complications: pneumonia (new infiltrate + either fever (>38.5 C) and white cell count >11,000 or fever and purulent secretions), severe atelectasis (requiring bronchoscopy), prolonged chest tubes (>6 days), and respiratory failure (intubation or prolonged mechanical ventilation (>24 hours).
These outcomes will be obtained by chart review by a nurse trained in the abstraction of the desired outcomes from the medical records and blinded to treatment assignment.
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Up to 6 months
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Quality of Life (QOL) Assessed by Chronic Respiratory Questionnaire
Periodo de tiempo: At baseline and at 6 months
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Chronic Respiratory Questionnaire (CRQ) (four domains: dyspnea, fatigue, emotional function and mastery).
This instrument will be the primary tool to assess QoL given that it was specifically designed for COPD.
Specifically, the CRQ represents one of the most well known, widely-applied, and psychometrically-sound patient reported outcomes for use in clinical trials involving patients with COPD.
Each domain includes 4 to 7 items, with each item graded on 7-point Likert scale; item scores within a domain are summated to provide a total score for each domain.
The endpoint value is the 6 month values minus the baseline values.
Therefore the endpoint score may range from minus-7 to 7. Higher scores indicate better HRQL.
A negative change from baseline to study completion indicates a worsening score.
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At baseline and at 6 months
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Quality of Life (QOL) Assessed by Linear Analog Self-Assessment
Periodo de tiempo: Up to 6 months
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LASA (single-item numerical analogue quality of life Questionnaire) individual QOL domain scores have been validated previously for lung cancer patient populations and for assessment of patient-reported outcomes in similar trials.
Survey is based on 6 questions that are scored on a 0-10 scale with 0 being "as bad as it can be" and 10 being "As good as it can be."
A negative change in score from baseline indicates a worsening score.
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Up to 6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Robert Benzo, MD, MSc, Mayo Clinic
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A221502
- NCI-2016-01105 (Identificador de registro: NCI Clinical Trial Reporting Program)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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