Trial Outcomes & Findings for Pulmonary Rehabilitation Before Lung Cancer Resection (NCT NCT02887521)

Last Updated: 2025-02-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

9 participants

Primary outcome timeframe

Up to 6 months

Results posted on

2025-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	4	5
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Pulmonary Rehabilitation Before Lung Cancer Resection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulmonary Rehabilitation (PR) n=4 Participants 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	Standard of Care n=5 Participants 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	Total n=9 Participants Total of all reporting groups
Age, Continuous	69.5 years n=5 Participants	77 years n=7 Participants	75 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Original plan for abstracting length of hospital stay from medical records did not occur due to study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: Original plan for abstracting post-operative complications manually from medical records did not occur due to study termination.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and at 6 months

Population: All patients who registered and completed the CRQ at baseline and study completion were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Pulmonary Rehabilitation (PR) n=4 Participants 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	Standard of Care n=3 Participants 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
Quality of Life (QOL) Assessed by Chronic Respiratory Questionnaire Change in CRQ Emotional function	0.8 units on a scale Interval -0.7 to 4.3	0.7 units on a scale Interval 0.3 to 2.0
Quality of Life (QOL) Assessed by Chronic Respiratory Questionnaire Change in CRQ Dyspnea	0.0 units on a scale Interval -0.9 to 0.4	-.6 units on a scale Interval -1.4 to 0.5
Quality of Life (QOL) Assessed by Chronic Respiratory Questionnaire Change in CRQ Fatigue	1.0 units on a scale Interval -2.0 to 4.3	1.5 units on a scale Interval 1.0 to 1.5
Quality of Life (QOL) Assessed by Chronic Respiratory Questionnaire Change in CRQ Mastery	0.7 units on a scale Interval -1.0 to 2.7	0.3 units on a scale Interval -0.3 to 0.8

SECONDARY outcome

Timeframe: Up to 6 months

Population: Original plan for collecting and analyzing this data did not occur due to study termination

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.

Outcome measures

Outcome data not reported

Adverse Events

Pulmonary Rehabilitation (PR)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberto Benzo, MD, MSc

Mayo Clinic

Phone: (507) 284-0561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60