Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer
NCT ID: NCT03352245
Last Updated: 2024-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2018-11-26
2020-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2).
Prescribed Activity
Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)
Control Group
Usual care group will receive standard of care management from their Oncologist.
No interventions assigned to this group
Interventions
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Prescribed Activity
Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)
Eligibility Criteria
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Inclusion Criteria
* Approval of the treating clinician
* Adult patients (age \>21 years) willing to wear a FitBitĀ® device (FitBit, Inc., San Francisco, CA)
* Access to a smartphone, agree to receive twice/daily text messages for 12 weeks (including any costs), and willingness to download the FitBit application to their smartphone.
* Low activity level as judged by a brief physical activity questionnaire (i.e., \<150 minutes/week of moderate-intensity exercise, \<75 minutes/week of vigorous aerobic exercise, or an equivalent combination).
Exclusion Criteria
* Communication impairment (as judged by the treating clinician)
* Treating clinician's request not to alter physical activity
* Physical inability to safely walk (as judged by the treating clinician)
21 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
VA Connecticut Healthcare System
FED
National Cancer Institute (NCI)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Brett Bade, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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References
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Bade BC, Gan G, Li F, Lu L, Tanoue L, Silvestri GA, Irwin ML. "Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study". BMC Cancer. 2021 Apr 1;21(1):352. doi: 10.1186/s12885-021-08084-0.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2000022225
Identifier Type: -
Identifier Source: org_study_id
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