Move For Surgery - A Novel Preconditioning Program

Phase 3

Completed

• Conditions: Lung Cancer, Nonsmall Cell
• Interventions: Device: Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group

• Registration Number: NCT03689634
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Study Start: 2018-10-15
• Primary Completion: 2021-10-01
• Study Completion: 2022-06-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Move For Surgery Preconditioning Program Intervention Group	Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group	-

Primary Outcome Measures

Name	Time	Method
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.	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

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

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada