NCT03902834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

January 30, 2018

Last Update Submit

April 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (5)

  • Rate of accrual

    12 months

  • Perioperative patient complications

    12 months

  • Cost per patient

    12 months

  • Patient-reported health-related quality of life

    12 months

  • Patient-reported health-related physical activity

    12 months

Study Arms (1)

Intervention

EXPERIMENTAL
Other: Fitbit

Interventions

FitbitOTHER

Use the wearable technology (Fitbit) and proven behavioural change techniques to precondition patients prior to lung cancer surgery

Also known as: Wearable Technology
Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

January 30, 2018

First Posted

April 4, 2019

Study Start

November 30, 2017

Primary Completion

September 12, 2018

Study Completion

September 12, 2018

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations