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Move For Surgery - A Novel Preconditioning Program (MFS)

Primary Purpose

Lung Cancer, Nonsmall Cell

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer, Nonsmall Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Move For Surgery Preconditioning Program Intervention Group

Standard Preoperative Care Group

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
September 26, 2018
Last Updated
June 28, 2023
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Hamilton Academic Health Sciences Organization
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1. Study Identification

Unique Protocol Identification Number
NCT03689634
Brief Title
Move For Surgery - A Novel Preconditioning Program
Acronym
MFS
Official Title
Move For Surgery - A Novel Preconditioning Program to Optimize Health Before Thoracic Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Hamilton Academic Health Sciences Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Nonsmall Cell

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Move For Surgery Preconditioning Program Intervention Group
Arm Type
Experimental
Arm Title
Standard Preoperative Care Group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Secondary outcome will include differences in the 36-Item Short Form Health Survey (SF-36) scores before and after the intervention.
Description
The quality of life as reported by patients will be compared.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

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Move For Surgery - A Novel Preconditioning Program

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