Move For Surgery - A Novel Preconditioning Program

NCT03689634 | Completed Phase 3

• 1 other identifier: SJHH-MFS-RCT
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer, Nonsmall Cell

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

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

  24 months

Study Arms (2)

Move For Surgery Preconditioning Program Intervention Group

EXPERIMENTAL

Device: Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group

Standard Preoperative Care Group

NO INTERVENTION

Interventions

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

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.

Move For Surgery Preconditioning Program Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Hamilton Academic Health Sciences Organization: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• Patel YS, Sullivan KA, Churchill IF, Beauchamp MK, Wald J, Mbuagbaw L, Fahim C, Hanna WC. Preconditioning program reduces the incidence of prolonged hospital stay after lung cancer surgery: Results from the Move For Surgery randomized clinical trial. Br J Surg. 2023 Oct 10;110(11):1467-1472. doi: 10.1093/bjs/znad252.

  PMID: 37643916 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: October 15, 2018
• Primary Completion: October 1, 2021
• Study Completion: June 1, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CA (1)