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Clinical Trials/NCT03689634
NCT03689634
Completed
Phase 3

Move For Surgery - A Novel Preconditioning Program to Optimize Health Before Thoracic Surgery: A Randomized Controlled Trial

St. Joseph's Healthcare Hamilton1 site in 1 country102 target enrollmentOctober 15, 2018

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Lung Cancer, Nonsmall Cell
Sponsor
St. Joseph's Healthcare Hamilton
Enrollment
102
Locations
1
Primary Endpoint
The primary outcome of the comparative trial will be length of stay (LOS) in hospital after surgery, which will also be used to measure speed of recovery from surgery and postoperative complications.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Lung cancer is the leading cause of cancer death in Canada. Most patients with this cancer will undergo treatment with major chest surgery that is associated with serious complications. As many as 50% of patients will suffer respiratory complications after surgery, keeping them in the hospital for extended periods of time. These long hospitalizations have a dramatic negative effect on the lives of those people, in addition to a large cost burden on our healthcare system. Traditionally, patients who suffer from complications are treated with rehabilitation AFTER the complications have occurred. But what if complications can be prevented BEFORE they happen? Having major chest surgery imposes great stress on the human body, one that is equivalent to running a marathon. Analogous to training before completing a marathon, the investigator designed Move For Surgery (MFS), a novel preconditioning program that encourages and empowers patients to improve their health prior to surgery. The investigator aims to demonstrate that patients who train with Move For Surgery will have lower respiratory complication rates, will recover better, and will leave the hospital sooner than their counterparts.

Registry
clinicaltrials.gov
Start Date
October 15, 2018
End Date
June 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wael Hanna

Associate Professor of Surgery

McMaster University

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • Clinical stage I, II, or IIIa non-small cell lung cancer (NSCLC)
  • Candidates for thoracic surgery, as determined by the operating surgeon

Exclusion Criteria

  • Clinical stage IIIb or IV NSCLC
  • Patients with affected mobility (wheelchair, walker)
  • Patients who use oxygen at home

Outcomes

Primary Outcomes

The primary outcome of the comparative trial will be length of stay (LOS) in hospital after surgery, which will also be used to measure speed of recovery from surgery and postoperative complications.

Time Frame: 24 months

LOS is a good surrogate measure for the speed of recovery from surgery (patients who recover faster leave hospital earlier) and postoperative complications (patients who do not suffer complications leave the hospital earlier).

Secondary Outcomes

  • Secondary outcome will include differences in the 36-Item Short Form Health Survey (SF-36) scores before and after the intervention.(24 months)

Study Sites (1)

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