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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)
Yale University
New Haven, Connecticut, United States
Overall Step Count
Participants will wear a Fitbit wrist band that will record step count.
Time frame: 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.
Time frame: baseline to 12 weeks.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline to 12 weeks
Vigorous Aerobic Exercise
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Time frame: baseline to 12 weeks
Change in C-reactive Protein (CRP)
The investigators will obtain serum CRP, a marker of inflammation.
Time frame: change from pre- to post-intervention (week 12)
Change in Leptin Level
The investigators will obtain serum leptin, a marker of glucose control. .
Time frame: change from pre- to post-intervention (week 12)
Change in Insulin Level
The investigators will obtain serum insulin level, a measure of glucose control.
Time frame: change from pre- to post-intervention (week 12)
Programmed Death - Ligand
The investigators will collect soluble PD- L1, a novel cancer marker.
Time frame: change from pre- to post-intervention (week 12)
Programmed Cell Death (PD-1)
The investigators will collect soluble PD- 1, a novel cancer marker.
Time frame: change from pre- to post-intervention (week 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.