Move For Surgery - A Novel Preconditioning Program

Lung Cancer, Nonsmall Cell Clinical Trial

— MFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689634
• Other study ID #: SJHH-MFS-RCT
• Status: Completed
• Phase: Phase 3
• Start date: October 15, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2023
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Nonsmall Cell

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Hamilton Academic Health Sciences Organization

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	24 months
Secondary	Secondary outcome will include differences in the 36-Item Short Form Health Survey (SF-36) scores before and after the intervention.	The quality of life as reported by patients will be compared.	24 months