Clinical trial NCT03352245: Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer
Official title: Assessing the Feasibility of a Patient-centered Activity Regimen in Patients With Advanced Stage Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasm Malignant
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: VA Connecticut Healthcare System
name: National Cancer Institute (NCI)
First posted: 2017-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of \>50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.


Eligibility criteria: Inclusion Criteria:

* Pathologic evidence of advanced non-small cell stage lung cancer (NSCLC)
* Approval of the treating clinician
* Adult patients (age \>21 years) willing to wear a FitBit® 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:

* Memory impairment (as judged by the treating clinician)
* 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)

Primary outcomes:
measure: Overall Step Count
timeFrame: baseline to 12 weeks
measure: Number of Weeks Participants Adhered to Step Count Recommendations
timeFrame: baseline to 12 weeks.
Secondary outcomes:
measure: Dyspnea
timeFrame: change from pre- to post-intervention (week 12)
measure: Depression
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Global Health Status
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Physical Functioning
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Role Functioning
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Emotional Functioning
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Fatigue
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Cognitive Functioning
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Nausea/Vomiting
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Pain
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Social Functioning
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Dyspnea
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Insomnia
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Appetite Loss
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Constipation
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Diarrhea
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Quality of Life: Financial Difficulties
timeFrame: change from pre- to post-intervention (week 12)
measure: Moderate Aerobic Exercise
timeFrame: baseline to 12 weeks
measure: Vigorous Aerobic Exercise
timeFrame: baseline to 12 weeks
measure: Change in C-reactive Protein (CRP)
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Leptin Level
timeFrame: change from pre- to post-intervention (week 12)
measure: Change in Insulin Level
timeFrame: change from pre- to post-intervention (week 12)
measure: Programmed Death - Ligand
timeFrame: change from pre- to post-intervention (week 12)
measure: Programmed Cell Death (PD-1)
timeFrame: change from pre- to post-intervention (week 12)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Brett Bade, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.