PreconditioningNCT03902834
Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery
A study testing Fitbit in people with Preconditioning and Lung Cancer, Nonsmall Cell, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preconditioning, Lung Cancer, Nonsmall Cell
- What is being tested?
- Fitbit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2017to 12 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible participants include patients with NSCLC set to undergo pulmonary resection.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Preconditioning, Lung Cancer, Nonsmall Cell
- Being tested
- Fitbit
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitOther
Also called Wearable Technology
Use the wearable technology (Fitbit) and proven behavioural change techniques to precondition patients prior to lung cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
Rate of accrual
Rate of accrual
Measured: 12 months
Perioperative patient complications
Perioperative patient complications
Measured: 12 months
Cost per patient
Cost per patient
Measured: 12 months
Patient-reported health-related quality of life
EuroQol-5Dimensions-5Levels (EQ-5D-5L)
Measured: 12 months
Patient-reported health-related physical activity
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start30 Nov 2017
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Hanna, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902834
- Sponsor's protocol ID
- BFCRS-333417
- Status last verified
- Apr 2019
- First submitted
- 30 Jan 2018
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03902834
- Acronym / sponsor ID
- BFCRS-333417
- Conditions
- Preconditioning, Lung Cancer, Nonsmall Cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Fitbit |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants include patients with NSCLC set to undergo pulmonary resection.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitAlso: Wearable TechnologyUse the wearable technology (Fitbit) and proven behavioural change techniques to precondition patients prior to lung cancer surgery | Other | Intervention |
Primary outcome
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.
5 secondary outcomes
Rate of accrual
Time frame: 12 months
Perioperative patient complications
Time frame: 12 months
Cost per patient
Time frame: 12 months
Patient-reported health-related quality of life
Time frame: 12 months
Patient-reported health-related physical activity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit in people with Preconditioning and Lung Cancer, Nonsmall Cell, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of Move for Surgery, as measured by a rate of compliance of >70% until program completion. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.