Lung Cancer, Nonsmall CellPhase 3MFSNCT03689634
Move For Surgery - A Novel Preconditioning Program
A Phase 3 study testing Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group in people with Lung Cancer, Nonsmall Cell, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell
- What is being tested?
- Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2018to 1 Jun 2022
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinical stage IIIb or IV NSCLC
- Patients with affected mobility (wheelchair, walker)
- Patients who use oxygen at home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Move For Surgery - A Novel Preconditioning Program to Optimize Health Before Thoracic Surgery: A Randomized Controlled Trial
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
- Being tested
- Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group
- 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.
Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Move For Surgery Preconditioning Program Intervention Group | Experimental | Not described Receives: Device: Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group |
| Standard Preoperative Care Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
The quality of life as reported by patients will be compared.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start15 Oct 2018
- Primary completion1 Oct 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer, Nonsmall CellStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Responsible party
- Principal investigator, Wael Hanna, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689634
- Sponsor's protocol ID
- SJHH-MFS-RCT
- Acronym
- MFS
- Status last verified
- Jun 2023
- First submitted
- 26 Sep 2018
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37643916
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move For Surgery - A Novel Preconditioning Program to Optimize Health Before Thoracic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03689634
- Acronym / sponsor ID
- MFS / SJHH-MFS-RCT
- Conditions
- Lung Cancer, Nonsmall Cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 28 Sep 2018 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Clinical stage IIIb or IV NSCLC
- Patients with affected mobility (wheelchair, walker)
- Patients who use oxygen at home
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 |
|---|---|---|
| Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention GroupParticipants 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. | Device | Move For Surgery Preconditioning Program Intervention Group |
Primary outcome
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.
Time frame: 24 months
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).
1 secondary outcome
Secondary outcome will include differences in the 36-Item Short Form Health Survey (SF-36) scores before and after the intervention.
Time frame: 24 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 3 Jul 2023.
- Derived from this study: PubMed 37643916Patel 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.
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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 Phase 3 study testing Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group in people with 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 3 inclusion and 3 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 3 Jul 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 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. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689634, which also lists 1 linked publication.
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 3 Jul 2023.