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Move For Surgery - A Novel Preconditioning Program (MFS)

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ClinicalTrials.gov Identifier: NCT03689634
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Hamilton Academic Health Sciences Organization
Information provided by (Responsible Party):
Wael Hanna, McMaster University

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.

Condition or disease Intervention/treatment Phase
Lung Cancer, Nonsmall Cell Device: Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Move For Surgery - A Novel Preconditioning Program to Optimize Health Before Thoracic Surgery: A Randomized Controlled Trial
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Move For Surgery Preconditioning Program Intervention Group Device: Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group
Participants randomized to this group will be be provided with a wearable activity tracker (Fitbit) for the duration of the study and asked to reach daily step goals.

No Intervention: Standard Preoperative Care Group



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Secondary outcome will include differences in the 36-Item Short Form Health Survey (SF-36) scores before and after the intervention. [ Time Frame: 24 months ]
    The quality of life as reported by patients will be compared.



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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

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

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): NCT03689634


Contacts
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Contact: Yogita Patel 905-522-1155 ext 35096 patelys@mcmaster.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Yogita Patel    905-522-1155 ext 35096    patelys@mcmaster.ca   
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Hamilton Academic Health Sciences Organization

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Responsible Party: Wael Hanna, Associate Professor of Surgery, McMaster University
ClinicalTrials.gov Identifier: NCT03689634     History of Changes
Other Study ID Numbers: SJHH-MFS-RCT
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 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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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases