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Non-small Cell Lung Cancer (NSCLC)Phase 3NCT02887521

Pulmonary Rehabilitation Before Lung Cancer Resection

A Phase 3 study testing education, rehabilitation and pedometer in people with Non-small Cell Lung Cancer (NSCLC) and Chronic Obstructive Pulmonary Disease (COPD), run by Alliance for Clinical Trials in Oncology at 7 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
education, rehabilitation and pedometer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
7 sitesin 2 countries
Study dates
28 Feb 2018to 25 Sep 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  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

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States6 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

Canada1 site

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

Other trials in Canada

About this study

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.

Read the 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.
  1. 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.

Being tested
education, rehabilitation, pedometer, surgery
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • educationOther

    pulmonary rehabilitation participant manual

  • rehabilitationProcedure or surgery

    pulmonary rehabilitation

  • pedometerDevice

    receive a pedometer

  • educationOther

    receive a pamphlet with exercises plus the standard course of care

  • surgeryProcedure or surgery

    patients undergo surgery

Study groups in NCT02887521
Study groupRoleWhat they receive
Pulmonary Rehabilitation (PR)ExperimentalPatients 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.
Receives: Other: education; Procedure: rehabilitation; Procedure: surgery
Standard of CareActive comparatorPatients 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.
Receives: Device: pedometer; Other: education; Procedure: surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 6 months

Secondary outcomes (3)

  1. 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.

    Measured: Up to 6 months

  2. 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.

    Measured: At baseline and at 6 months

  3. 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.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study start28 Feb 2018
  3. Primary completion22 Apr 2019
  4. Study completion25 Sep 2019

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887521
Sponsor's protocol ID
A221502
Other IDs
NCI-2016-01105
Status last verified
Jan 2025
First submitted
30 Aug 2016
Last updated
3 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31618297

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing education, rehabilitation and pedometer in people with Non-small Cell Lung Cancer (NSCLC) and Chronic Obstructive Pulmonary Disease (COPD), run by Alliance for Clinical Trials in Oncology at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Length of Stay Assessed With Complete Admission Hospital Records (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02887521, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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