Pulmonary Rehabilitation Before Lung Cancer Resection

NCT02887521 | Terminated Phase 3 Results DMC

• 2 other identifiers: A221502NCI-2016-01105
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 7

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.

Conditions

Non-small Cell Lung Cancer (NSCLC); Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Post-operative Pulmonary Complications Assessed by Chart Review

  Up to 6 months

• Quality of Life (QOL) Assessed by Chronic Respiratory Questionnaire

  At baseline and at 6 months

• Quality of Life (QOL) Assessed by Linear Analog Self-Assessment

  Up to 6 months

Study Arms (2)

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.

Other: education; Procedure: rehabilitation; Procedure: surgery

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.

Device: pedometer; Other: education; Procedure: surgery

Interventions

education OTHER

pulmonary rehabilitation participant manual

Pulmonary Rehabilitation (PR)

rehabilitation PROCEDURE

pulmonary rehabilitation

Pulmonary Rehabilitation (PR)

pedometer DEVICE

receive a pedometer

Standard of Care

surgery PROCEDURE

patients undergo surgery

Pulmonary Rehabilitation (PR); Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Related Publications (1)

• 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.

  PMID: 31618297 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pulmonary Disease, Chronic Obstructive

Interventions

Educational Status; Rehabilitation; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Roberto Benzo, MD, MSc
• Organization: Mayo Clinic

benzo.roberto@mayo.edu

(507) 284-0561

Study Officials

• Robert Benzo, MD, MSc

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 2, 2016
• Study Start: February 28, 2018
• Primary Completion: April 22, 2019
• Study Completion: September 25, 2019
• Last Updated: February 3, 2025
• Results First Posted: June 23, 2020

Record last verified: 2025-01

Locations

US (6); CA (1)