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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03902834
Other study ID # BFCRS-333417
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2017
Est. completion date September 12, 2018

Study information

Verified date April 2019
Source St. Joseph's Healthcare Hamilton
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 12, 2018
Est. primary completion date September 12, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Canada St. Joseph's Healthcare Hamilton Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Rate of accrual Rate of accrual 12 months
Secondary Perioperative patient complications Perioperative patient complications 12 months
Secondary Cost per patient Cost per patient 12 months
Secondary Patient-reported health-related quality of life EuroQol-5Dimensions-5Levels (EQ-5D-5L) 12 months
Secondary Patient-reported health-related physical activity International Physical Activity Questionnaire - Short Form (IPAQ-SF) 12 months
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