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Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902834
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Wael Hanna, St. Joseph's Healthcare Hamilton

Brief Summary:
Wearable technology is increasingly being used to promote healthy behaviour. In this study, the investigators propose the development and evaluation of Move for Surgery, which utilizes a wearable activity bracelet (Fitbit) and proven behavioural change techniques, for preconditioning of patients prior to lung cancer surgery. The primary outcome of this study will be compliance with Move for Surgery, as a surrogate measure for feasibility. Secondary outcomes, including accrual rates, perioperative pulmonary complications, cost per patient, and patient satisfaction, will also be collected. The investigators have partnered with the Canadian Partnership Against Cancer (CPAC) and Lung Cancer Canada (LCC) to develop Move for Surgery. The ultimate goal of this preliminary study is to lay the groundwork for a subsequent comparative trial to evaluate the impact of Move for Surgery on postoperative complications in the thoracic surgery population.

Condition or disease Intervention/treatment Phase
Preconditioning Lung Cancer, Nonsmall Cell Other: Fitbit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : September 12, 2018
Actual Study Completion Date : September 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Other: Fitbit
Use the wearable technology (Fitbit) and proven behavioural change techniques to precondition patients prior to lung cancer surgery
Other Name: Wearable Technology




Primary Outcome Measures :
  1. The feasibility of Move for Surgery, as measured by a rate of compliance of >70% until program completion. [ Time Frame: 12 months ]
    The feasibility of Move for Surgery, as measured by a rate of compliance of >70% until program completion.


Secondary Outcome Measures :
  1. Rate of accrual [ Time Frame: 12 months ]
    Rate of accrual

  2. Perioperative patient complications [ Time Frame: 12 months ]
    Perioperative patient complications

  3. Cost per patient [ Time Frame: 12 months ]
    Cost per patient

  4. Patient-reported health-related quality of life [ Time Frame: 12 months ]
    EuroQol-5Dimensions-5Levels (EQ-5D-5L)

  5. Patient-reported health-related physical activity [ Time Frame: 12 months ]
    International Physical Activity Questionnaire - Short Form (IPAQ-SF)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible participants include patients with NSCLC set to undergo pulmonary resection.

Exclusion Criteria:

  • There will be no exclusion based on functional status in this feasibility study; rather, a subsequent analysis of participant demographics will be performed to inform future phases of this study.

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): NCT03902834


Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
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Responsible Party: Wael Hanna, Assistant Professor of Surgery, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT03902834    
Other Study ID Numbers: BFCRS-333417
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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