Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer

Yale University

Status: Completed

Conditions: Lung Neoplasm Malignant

Treatments: Behavioral: Prescribed Activity

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT03352245

1P50CA196530-01 (U.S. NIH Grant/Contract)

2000022225

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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).

Treatment:

Behavioral: Prescribed Activity

Control Group

No Intervention group

Description:

Usual care group will receive standard of care management from their Oncologist.