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

Study Overview
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Brief Summary
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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.

Official Title
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Assessing the Feasibility of a Patient-centered Activity Regimen in Patients With Advanced Stage Lung Cancer

Conditions
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Lung Neoplasm Malignant

Intervention / Treatment
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* Behavioral: Prescribed Activity


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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). | Behavioral: Prescribed Activity<br>* Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)<br>|
| No Intervention: Control Group<br>Usual care group will receive standard of care management from their Oncologist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Step Count | Participants will wear a Fitbit wrist band that will record step count. | baseline to 12 weeks | 
| Number of Weeks Participants Adhered to Step Count Recommendations | Exercise Adherence will be defined as (the number of weeks a subject follows the activity prescription)/(the number of usable weeks). A week is considered usable if 5/7 days of step counts are available, and days with <200 steps/day are considered not usable. | baseline to 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | Assessed via self-report using the Modified Medical Research Council. Dyspnea Scale, a single-item scale scored 0-4; higher score indicates worse dyspnea. | change from pre- to post-intervention (week 12) | 
| Depression | Assessed via self-report using the Patient Health Questionnaire, Depression Module (PHQ-9). a 9-item questionnaire that assesses depressive symptoms over the preceding two weeks. Each item is scored 0-3 (0 = Not at all; 1 = Several days; 2 = More than half of days; 3 = Nearly every day). A total score is calculated by taking the sum of questions 1-9, and a higher score indicates worse depression. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Global Health Status | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales: Global health status/Quality of Life (QoL) scale, range 0-100, higher score = better quality of life. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Physical Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measure physical functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Role Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures role functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Emotional Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures emotional functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Fatigue | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures fatigue. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Cognitive Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures cognitive functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Nausea/Vomiting | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures nausea and vomiting The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Pain | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures pain. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Social Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures social functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Dyspnea | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure dyspnea. The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Insomnia | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure insomnia. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Appetite Loss | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure appetite loss The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Constipation | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure constipation. The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Diarrhea | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure diarrhea. The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) | 
| Change in Quality of Life: Financial Difficulties | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure financial difficulties. The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) | 
| Moderate Aerobic Exercise | The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes. | baseline to 12 weeks | 
| Vigorous Aerobic Exercise | The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes. | baseline to 12 weeks | 
| Change in C-reactive Protein (CRP) | The investigators will obtain serum CRP, a marker of inflammation. | change from pre- to post-intervention (week 12) | 
| Change in Leptin Level | The investigators will obtain serum leptin, a marker of glucose control. . | change from pre- to post-intervention (week 12) | 
| Change in Insulin Level | The investigators will obtain serum insulin level, a measure of glucose control. | change from pre- to post-intervention (week 12) | 
| Programmed Death - Ligand | The investigators will collect soluble PD- L1, a novel cancer marker. | change from pre- to post-intervention (week 12) | 
| Programmed Cell Death (PD-1) | The investigators will collect soluble PD- 1, a novel cancer marker. | change from pre- to post-intervention (week 12) |