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Pulmonary Rehabilitation Before Lung Cancer Resection

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ClinicalTrials.gov Identifier: NCT02887521
Recruitment Status : Terminated (Poor accrual)
First Posted : September 2, 2016
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Chronic Obstructive Pulmonary Disease (COPD) Other: education Procedure: rehabilitation Device: pedometer Procedure: surgery Phase 3

Detailed Description:

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:

  1. 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.
  2. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pulmonary Rehabilitation Before Lung Cancer Resection
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : April 22, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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.
Other: education
pulmonary rehabilitation participant manual

Procedure: rehabilitation
pulmonary rehabilitation

Procedure: surgery
patients undergo surgery

Active Comparator: Control
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.
Device: pedometer
receive a pedometer

Other: education
receive a pamphlet with exercises plus the standard course of care

Procedure: surgery
patients undergo surgery




Primary Outcome Measures :
  1. Hospital length of stay assessed with complete admission hospital records [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Post-operative pulmonary complications assessed by chart review [ Time Frame: Up to 6 months ]
  2. Quality of life (QOL) assessed by Chronic Respiratory Questionnaire [ Time Frame: Up to 6 months ]
  3. Quality of life (QOL) assessed by Medical Research Council Dyspnea Score [ Time Frame: Up to 6 months ]
  4. Quality of life (QOL) assessed by Linear Analog Self-Assessment [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. 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.
  2. Patient has a doctor diagnosis of COPD.
  3. 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).
  4. Age ≥ 18 yrs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887521


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Wisconsin
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Robert Benzo, MD, MSc Mayo Clinic

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02887521     History of Changes
Other Study ID Numbers: A221502
NCI-2016-01105 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases