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

Primary Purpose

Preconditioning, Lung Cancer, Nonsmall Cell

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fitbit
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preconditioning

Eligibility Criteria

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

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.

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

The feasibility of Move for Surgery, as measured by a rate of compliance of >70% until program completion.
The feasibility of Move for Surgery, as measured by a rate of compliance of >70% until program completion.

Secondary Outcome Measures

Rate of accrual
Rate of accrual
Perioperative patient complications
Perioperative patient complications
Cost per patient
Cost per patient
Patient-reported health-related quality of life
EuroQol-5Dimensions-5Levels (EQ-5D-5L)
Patient-reported health-related physical activity
International Physical Activity Questionnaire - Short Form (IPAQ-SF)

Full Information

First Posted
January 30, 2018
Last Updated
April 4, 2019
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT03902834
Brief Title
Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery
Official Title
Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
September 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Fitbit
Other Intervention Name(s)
Wearable Technology
Intervention Description
Use the wearable technology (Fitbit) and proven behavioural change techniques to precondition patients prior to lung cancer surgery
Primary Outcome Measure Information:
Title
The feasibility of Move for Surgery, as measured by a rate of compliance of >70% until program completion.
Description
The feasibility of Move for Surgery, as measured by a rate of compliance of >70% until program completion.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of accrual
Description
Rate of accrual
Time Frame
12 months
Title
Perioperative patient complications
Description
Perioperative patient complications
Time Frame
12 months
Title
Cost per patient
Description
Cost per patient
Time Frame
12 months
Title
Patient-reported health-related quality of life
Description
EuroQol-5Dimensions-5Levels (EQ-5D-5L)
Time Frame
12 months
Title
Patient-reported health-related physical activity
Description
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
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

Plan to Share IPD
No

Learn more about this trial

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

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