| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01105 | Registry Identifier | NCI Clinical Trial Reporting Program |
Not provided
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Poor accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a study funded by the National Institute of Health. The rationale for the need of this research is the lack of any well proven risk-reducing intervention that may decrease the morbidity of lung cancer resection in patients with COPD or that may improve their quality of life trajectory, a meaningful outcome in the overall disease progression. The proposed intervention is unique as it combines exercise and behavioral interventions that were pilot tested in a randomized single-blinded controlled design in the proposed population and proved feasible and potentially effective. The aim is to test the effect of the proposed rehabilitation on length of stay, pulmonary complications and quality of life trajectory.
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.
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.
Patients will be followed at 3 and 6 months post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Rehabilitation (PR) | Experimental | 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. |
|
| Standard of Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| education | Other | pulmonary rehabilitation participant manual |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay Assessed With Complete Admission Hospital Records | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pulmonary Complications Assessed by Chart Review | 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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| Name | Affiliation | Role |
|---|---|---|
| Robert Benzo, MD, MSc | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States | ||
| Rush University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31618297 | Derived | Perrotta F, Cennamo A, Cerqua FS, Stefanelli F, Bianco A, Musella S, Rispoli M, Salvi R, Meoli I. Effects of a high-intensity pulmonary rehabilitation program on the minute ventilation/carbon dioxide output slope during exercise in a cohort of patients with COPD undergoing lung resection for non-small cell lung cancer. J Bras Pneumol. 2019 Oct 14;45(6):e20180132. doi: 10.1590/1806-3713/e20180132. eCollection 2019. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. education: pulmonary rehabilitation participant manual rehabilitation: pulmonary rehabilitation surgery: patients undergo surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 28, 2017 |
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| rehabilitation |
| Procedure |
pulmonary rehabilitation |
|
| pedometer | Device | receive a pedometer |
|
| education | Other | receive a pamphlet with exercises plus the standard course of care |
|
| surgery | Procedure | patients undergo surgery |
|
| Up to 6 months |
| Quality of Life (QOL) Assessed by Chronic Respiratory Questionnaire | 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. | At baseline and at 6 months |
| Quality of Life (QOL) Assessed by Linear Analog Self-Assessment | 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. | Up to 6 months |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| FG001 | 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. pedometer: receive a pedometer education: receive a pamphlet with exercises plus the standard course of care surgery: patients undergo surgery |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients that began protocol intervention were included in this analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. education: pulmonary rehabilitation participant manual rehabilitation: pulmonary rehabilitation surgery: patients undergo surgery |
| BG001 | 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. pedometer: receive a pedometer education: receive a pamphlet with exercises plus the standard course of care surgery: patients undergo surgery |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Length of Stay Assessed With Complete Admission Hospital Records | 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. | Original plan for abstracting length of hospital stay from medical records did not occur due to study termination | Posted | Up to 6 months |
|
| ||||||||||||||||||||||
| Secondary | Post-operative Pulmonary Complications Assessed by Chart Review | 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. | Original plan for abstracting post-operative complications manually from medical records did not occur due to study termination. | Posted | Up to 6 months |
| |||||||||||||||||||||||
| Secondary | Quality of Life (QOL) Assessed by Chronic Respiratory Questionnaire | 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. | All patients who registered and completed the CRQ at baseline and study completion were included in this analysis. | Posted | Median | Full Range | units on a scale | At baseline and at 6 months |
| ||||||||||||||||||||
| Secondary | Quality of Life (QOL) Assessed by Linear Analog Self-Assessment | 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. | Original plan for collecting and analyzing this data did not occur due to study termination | Posted | Up to 6 months |
|
We do not anticipate any adverse events related to participation in this study. PR has no reported risks based on 3000 patients with severe COPD in the National Emphysema treatment trial that underwent exercise training in more intensity compared to the one planned in this study. Therefore, no adverse events assessment were collected per protocol.
We do not anticipate any adverse events related to participation in this study. PR has no reported risks based on 3000 patients with severe COPD in the National Emphysema treatment trial that underwent exercise training in more intensity compared to the one planned in this study. Therefore, no adverse events assessment were collected per protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. education: pulmonary rehabilitation participant manual rehabilitation: pulmonary rehabilitation surgery: patients undergo surgery | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. pedometer: receive a pedometer education: receive a pamphlet with exercises plus the standard course of care surgery: patients undergo surgery | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto Benzo, MD, MSc | Mayo Clinic | (507) 284-0561 | benzo.roberto@mayo.edu |
| May 6, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| D012046 | Rehabilitation |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| OG001 | 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. pedometer: receive a pedometer education: receive a pamphlet with exercises plus the standard course of care surgery: patients undergo surgery |
|
| OG001 | 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. pedometer: receive a pedometer education: receive a pamphlet with exercises plus the standard course of care surgery: patients undergo surgery |
|
|
| OG001 |
| 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. pedometer: receive a pedometer education: receive a pamphlet with exercises plus the standard course of care surgery: patients undergo surgery |
|